New study seeks to understand how the brain optimizes walking in older adults
The purpose of this study is to understand how people control walking and balance. We are looking for healthy older adults who are interested in joining the study. Participants will walk on a treadmill while using an interactive display that will help them modify their walking pattern. We will determine how these modifications influence oxygen consumption during walking and measures of balance.
An ACromegaly, open-label, multi-CEnter, Safety
monitoring program for treating patients with SOM230
(pasireotide) LAR who have need to receive medical
therapy (ACCESS)
Purpose and rationale: The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to
pasireotide LAR (long acting release) while regulatory approval for pasireotide is sought.
Intervention: Pasireotide LAR 40 mg i.m. depot injection every 28 ( 2) days, administered at the
investigative site follow with safety accessment including Monitoring and recording (SAE),
hematology, blood chemistry (including fasting glucose), liver
function parameters, coagulation parameters, HbA1c, free T4, thyroid-stimulating
hormone (TSH), serum cortisol, plasma adrenocorticotropic hormone (ACTH),
urinalysis, physical examination including vital signs and body weightm 12-lead ECGs , Gallbladder ultrasound.
Objectives
- To document the safety of pasireotide LAR in patients with acromegaly
- To document the overall safety and tolerability of pasireotide LAR in patients
with acromegaly
Study population/Sample characteristics: It is expected that approximately 40 adult male and female patients with active
acromegaly for whom medical therapy is appropriate will be enrolled. Eligible
patients must have demonstrated elevated (>1.3 x ULN) circulating IGF-1
concentrations (age- and sex-adjusted) and random GH concentration >1 g/L
within 28 ( 2) days prior to screening.
Study Methodology: Patients will be treated until pasireotide LAR becomes commercially available and
reimbursed or until 31 December 2015, whichever occurs first. Patients will be
transitioned to commercial pasireotide LAR as quickly as possible (no longer than
6 months) after commercial availability.
Phytoserms for menopause symptoms and age associated memory decline
Background and rationale:Selective estrogen receptor (ER) targeting may be a novel therapeutic target for the development of therapies for a range of conditions including cognitive impairment and age-related ovarian failure (menopause). There are plausible mechanisms by which ER receptor stimulation could lead to improved cognition, feelings of well being, reduced risks for cognitive impairment and improved vasomotor symptoms.A formulation composed of rationally-selected ER-selective phytoestrogens (phytoSERMs) was developed that provides a greater effect than the various food supplements ("nutraceuticals") that are mixtures with both ER and ER selective components. This formulation is composed of content that includes synergistic rather than antagonistic effects on estrogen receptors and could likely generate salutary therapeutic effects. The formulation enhances ER responses by adding equol to genistein and daidzein in equal amounts moderating potencial influences of inter-individual differences in the production of equol. Advantages of the formulation are: (1) reduction of antagonistic interactions that occur in complex soy-derived isoflavone preparations; and (2) minimization of adverse effects associated with ER activation in reproductive tissues. Thus, it may serve as an alternative to current over-the-counter therapies.Primary objectives and pupose:To examine in a randomized, placebo-controlled trial of 12 weeks duration evidence for safety, improved cognitive performance and vasomotor symptoms for a specific phytoSERM formulation Secondary objectives:1. To assess single-dose pharmacokinetics of the three constituents of phytoSERM combination over 24 hours in a subset of 18 participants randomly assigned 100 mg, 50 mg, or placebo tablets.2. To assess safety, tolerability of a 100 mg and 50 mg daily dose compared to placebo over 4 weeks3. To assess potential efficacy indicators of phytoSERM combination on cognitive performance and vasomotor symptoms by means of a 4-week treatment, 2 period, placebo-controlled crossover design for a subset of participants4. To develop biomarkers for response (i.e., for peripheral lipid peroxidation and mitochondrial function)Study design:Two stage, dose-range, double-blinded, parallel-group, placebo-controlled adaptive design 12 week treatment duration trial; with an embedded 2-period, 4-week treatment, crossover design for a subset of participants; and an embedded single-dose, 24 hour, pharmacokinetic study for a subset of participants. Allocation ratio will initially be 1:1:1, 100 mg, 50 mg, and placebo dose for the first 36 participants, with a possible change in allocation based on the adaptation (see protocol)Study endpoints:Adverse events over the first 4 weeks, and over 12 weeks;Cognitive performance on a 6-test battery, vasomotor symptoms, and behavioral symptoms at 4, 8, and 12 weeks.Blood levels of the three constituents of phytoSERM combination over 24 hours in the subset in the pharmacokinetic study; and blood levels at 4, 8 and 12 weeks for all participantsBlood for biomarker development at baseline, 4, 8, and 12 weeksEligibility criteria:Generally healthy, peri to postmenopausal women, ages 45 to 60, intact uteri and ovaries, last natural menstrual cycle completed from 60 days to less than 4 years prior to screening, having at least 1 cognitive complaint and 1 vasomotor-related symptom per day (on the Memory Assessment Questionnaire and Greene Climacteric Scale). Intervention:Oral tablets consisting of equal parts genestein, daidzein, and S-equol) totaling 100 mg per tablet and 50 mg per tablet; and mathching placeboProcedures and data collection: At baseline, physical exam, neuropsychological tests, vasomotor symptoms and mood scales;In person visits for screening, baseline, weeks 4, 8, and 12 during which medication effects will be assessed, cognitive and behavioral tests performed, and blood for plasma levels and biomarkers obtained; Telephone contacts at weeks 1, 2, 6, and 10; An in-person visit or telephone contact at 16 weeks (4 weeks after discontinuation); Blood samples for drug levels and pharmacokinetics during the first 24 hours for the subset participating;Blood at baseline, weeks 4, 8, and 12 for drug levels and biomarker development for the whole sampleStatistical considerations:Two-stage adaptive design. Analysis of first stage at 4 weeks after 36 participants are randomized and followed: Primary analysis will use Generalized Estimating Equation (GEE) methods to assess group differences in the outcomes in a modified intent-to-treat sample (i.e., randomized, took at least one dose, and had at least one follow-up with outcomes measures. Observed cases (at least 80% compliant and completed all outcomes) will be assessed in secondary analyses
Join a USC Study on Vaping and E-Cigarette Use
<p>The number of people who vape and use e-cigarettes has been increasing, particularly among young adults. We want to examine how factors associated with vaping and e-cigarette use, such as flavoring and nicotine level, effect people's thoughts, feelings, and behaviors.</p><p><br></p>
A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)
The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass through the endoscope that is already in place for the endoscopic ultrasound guided fine needle aspiration procedure, and an additional biopsy will be taken. This technique is experimental because biopsy forceps are routinely used in gastrointestinal endoscopy, but are not routinely used to obtain biopsies of the pancreas.
A Clinical Research Study for Adults Living with Stable Vitiligo
<p>The purpose of this study is to evaluate the safety and effectiveness of a procedure using the RECELL® System for repigmentation of stable vitiligo. Stable vitiligo means that for at least 12 months: </p><p>• Areas affected by loss of pigment have not increased in size. </p><p>• No new areas with pigment loss have developed. </p><p>The RECELL System is used to prepare a suspension (a liquid solution) of skin cells using a small sample of your own pigmented skin. The suspension made using your own skin includes cells responsible for pigmentation and will be applied on a depigmented area of your skin.</p>
Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model
Some stroke patients have severe weakness in one arm and must rely on their less-affected arm for daily activities. Previous research has shown that in some patients, the less-affected arm also experiences weakness due to the stroke. This research is being done to find out if the less-affected arm can be trained to perform faster and better during daily activities. Approximately 180 people will take part in this research study at Hershey Medical Center and University of Southern California.
Testing a new drug to prevent Alzheimer's disease and dementia
<p>Do any of your friends, family, or loved ones have problems remembering or have developed Alzheimer’s disease? The USC Alzheimer Disease Research Center is testing how well a drug may help to prevent the loss of memory. The research team is looking for volunteers (ages 60 to 75) who do not have signs of cognitive problems (meaning that their speech, thinking, and memory are fine compared to other people of the same age). </p><p>If you're eligible and choose to take part, you'll be one of the few people that can join the fight against Alzheimer's disease. But preventing such a disease won't happen overnight. The trial will run for between 5 and 8 years.</p>
Testing a new drug to reduce anxiety and agitation in people with Alzheimer's disease and dementia
<p>A person with Alzheimer's often feels anxious or upset easily. They might be restless, unable to sleep or pace back and forth. These problems, called agitation, can keep them from a normal day-and-night routine and might become harmful for your loved one or their caregivers. </p><p>Can FDA-approved medication that treats sadness and anxiety also help with agitation? USC Alzheimer Disease Research Center is looking for volunteers with any form of dementia (Alzheimer's disease) to join our 24-week study of Escitalopram to reduce agitation. </p><p>Volunteers and their caregivers will receive structured and personalized resources and therapies. Participants will receive Escitalopram for 12 weeks, with in-person visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person visits.</p>
USC study investigates the benefits or health risks of vaping and smoking
Researchers at USC are seeking study participants who vape or smoke as well as non-smokers in the Los Angeles area. The purpose of the research is to study the health benefits and risks of electronic cigarettes (e-cigs). Your participation will help to better understand the potential effects of e-cigs on the human body.
Need Help Quitting Cigarettes?
<p>Do you want to quit smoking, but not sure how? Are you having a hard time finding resources to help you take the first step towards quitting?</p><p>The researchers at the USC Health, Emotion, and Addiction Laboratory are looking for cigarette smokers between the ages of 21 and 65 years old who want to kick the habit.</p><p><br></p><p><br></p>
A Multicenter, Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment with Cimzia
This is a multicenter prospective study evaluating the placental transfer of certolizumab pegol (CZP) by measuring concentration of CZP in infants born to mothers who are on this drug during pregnancy. Certolizumab is a drug that is approved for use in Crohn's disease, rheumatoid arthritis and ankylosing spondylitis. Recent evidence suggests that certolizumab pegol does not cross the placenta, unlike other anti-tumor necrosis factor drugs. The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants. Blood samples will be measured in the infant, mother, and umbilical cord at birth. Additionally, blood samples will be collected from the infant at Week 4 and Week 8 after birth in order to assess the pharmacokinetics (PK) of CZP in infants after birth. The secondary and exploratory objectives are to assess the concentrations of CZP, anti-CZPantibodies, and polyethylene glycol (PEG) in the 3 sources of blood samples at the time of birth(infant, mother, and umbilical cord) and in the infants at 4 weeks and 8 weeks after birth. Although this study is noninterventional regarding treatment with CZP, it is consideredinterventional due to the collection of blood samples that are not part of routine clinical practice.The study will only include pregnant women who have decided to continue or start treatment withCZP for an approved indication in accordance with their treating physician prior to beingrecruited into the study. Approximately 30 pregnant subjects are planned to be screened in order to enroll 20 subjects (blood samples provided by the mother and infant at delivery/birth). To beeligible to participate in the study, subjects must be 30 weeks pregnant at the start of screening,and expecting to use CZP within 35 days prior to expected delivery date. The primary PK variable is plasma concentration of CZP in the infant at birth. Secondary andexploratory variables include plasma concentrations of CZP, anti-CZP antibodies, and PEG. In addition, safety variables are adverse events (AEs) which will be assessed by a Safety Follow-up phone assessment for mother and infant performed 5 weeks (5 days) after the final sample is obtained. Subjects who withdraw prematurely will have a Safety Follow-Up telephone contact (for mother and infant) 5 weeks (5 days) after withdrawing from the study.
A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
OBJECTIVES:
Primary
- Compare the event-free and overall survival of patients with newly diagnosed localized
Ewing's sarcoma treated with doxorubicin hydrochloride, cyclophosphamide, vincristine,
etoposide, and ifosfamide with vs without topotecan hydrochloride.
- Compare the side effects of these regimens in these patients.
Secondary
- Evaluate initial tumor size as a prognostic factor for event-free survival of these
patients.
- Evaluate histological response as a prognostic factor for event-free survival of these
patients.
- Continue evaluation of biologic markers both as related to prognosis and as eventual
therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1.
- Evaluate radiologic response by positron emission tomography as a prognostic factor for
event-free survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(≤ 17 vs ≥ 18 years of age) and primary tumor site (pelvic vs nonpelvic [including
extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3,
7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks
1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and
ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and
16. Patients undergo local therapy comprising surgical resection in approximately week
18 and/or radiotherapy beginning in approximately week 19. Patients then receive
vincristine as above in weeks 19-21, 28-30, 34-36, 40-42, and 46-51; dexrazoxane
hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above
in weeks 19 and 28; cyclophosphamide as above in weeks 19, 28, 34, 40, 46, and 49; and
ifosfamide and etoposide as above in weeks 22, 25, 31, 37, and 43.
- Arm II: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks
1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1
and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1
hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour
on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days
1 and 2 in weeks 7 and 16. Patients undergo local therapy comprising surgical resection
in approximately week 18 and/or radiotherapy beginning in approximately week 19.
Patients then receive vincristine as above in weeks 19-21, 28-33, 37-42, and 46-48;
topotecan hydrochloride as above in weeks 19, 31, and 40; cyclophosphamide IV over 30
minutes in weeks 19, 31, and 40 and IV over 1 hour in weeks 28, 37, and 46; ifosfamide
and etoposide as above in weeks 22, 25, 34, 43, and 49; dexrazoxane hydrochloride IV
over 15 minutes on days 1 and 2 in weeks 37 and 46; and doxorubicin hydrochloride as
above in weeks 28, 37, and 46.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 528 patients will be accrued for this study.
Join a USC Study on Vaping and E-Cigarette Use for Cigarette Smokers
The number of people who vape and use e-cigarettes has been increasing, particularly among young adults. We want to examine how factors associated with vaping and e-cigarette use, such as flavoring and nicotine level, effect people's thoughts, feelings, and behaviors.
ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
The ENRICH trial will compare the outcomes between early surgical intervention using the
BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical
approach includes a combination of available technologies, including the FDA-cleared NICO
BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot
evacuation. The medically managed cohort will be treated according the Clinical
Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA
Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy
will be determined by demonstrating a 10% improvement in functional outcome, as determined
by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
Data suggests improved mortality rates and potential functional benefits of surgical ICH
evacuation. The methodology proposed for this trial was tested in a preliminary series of 39
patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et
al.). These results were replicated in a single center retrospective series of 18 patients
(Bauer et al.). Despite positive results of both studies and the widely accepted benefit of
the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting
the use of these techniques in ICH is needed for the technique to become universally
validated.
Recruiting | Subcortical Intracerebral Hemorrhage | Site Unknown
ST Monitoring to Detect ACS Events in ICD Patients
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this
study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the
Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St
Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the
device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect
clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by
demonstrating a low percentage of patients with false positive events.
Active, not recruiting | Atherosclerosis | Multisite
LGBTQ+ Smokers & Their Partners Who Want to Quit Smoking
This study is about understanding attempts to quit cigarette smoking in couples. Your participation will help determine better treatment efforts for couples who smoke that want to quit. The study is being funded by the California Tobacco Related Disease Prevention Program.
CHLA Research Study on Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia
Anemia is a condition where the body is not making enough red blood cells to transport oxygen. The objective of this study is to learn how anemia may affect the oxygen delivery to the brain as measured by magnetic resonance imaging (MRI). By studying this, we hope to better identify people who may benefit from correction of their anemia by iron therapy.
Exploring Life Events Prior to Death by Suicide
<p>We are interested in creating better means of suicide prevention. One way to do this is by discussing suicide with those who have lost a loved one. If you are a survivor of loss, we want to hear the story of your loved one. We believe that by investigating the experiences of an individual prior to their death, we can better understand important risks that are often overlooked in current suicide prevention efforts. </p><p> This information may help to build better connections to prevent others from going through this loss. </p>
A Mobile Mindfulness App for U.S. Veterans: Mind Guide (Beta-Test Phase)
The purpose of this study is to examine how mobile apps that focus on mindfulness techniques and stress reduction skills can help post-9/11 veterans. Several stand-alone apps for phones have been developed, but they have yet to be tested to see if they are helpful for veterans who may living with stress or may be drinking alcohol at levels higher than they would like.
RESTORE: WeaRablEs for Stroke FuncTiOn in the NatuRal Environment
<p>One of the most frequent consequences of a stroke is arm and hand motor impairment. In fact, more than 60% of stroke survivors have motor impairments on one side of the body, which may limit participation in everyday activities and quality of life. To date, only few studies look at what influences motor recovery, apart from capacity. </p><p>This study aims to better understand what influences how stroke survivors choose to use the more affected arm and hand in everyday activities, such as confidence in using the arm or positive social interactions. </p>
Not yet recruiting | stroke; rehabilitation; arm; health technology | Not Multisite
Development of an online mindfulness program for stroke survivors and their caregivers
This study aims to test the satisfaction and ease-of-use of an online mindfulness program. The program is specifically designed to increase mindfulness for stroke survivors and their caregivers or loved ones. We are particularly interested to obtain feedback on the content of the program and the website used to offer it. The feedback and suggestions will help us to create a final version that is easy to understand and relevant for stroke survivors and caregivers. This study will be done virtually (no face-to-face visit).
Suicide Risk - Mechanisms of Proximal Suicide Risk
<p>Suicide is the second leading cause of death among young adults in the United States. Some types of thinking patterns and feelings may differ in people with a history of depression and suicidal thoughts. However, not enough is known about how the brain influences the way people feel, like how people help themselves feel better. </p><p> The purpose of this study is to better understand how people’s thinking affects their feelings, and how this might be related to risk for (or protection against) suicidal thinking and behavior.</p>
CHLA Research Study on Childhood Outcomes of Preterm Brain Abnormalities
<p>The purpose of this CHLA Research Study is to collect and compare information from your child's magnetic resonance imaging (MRI) scans, neurological exam and neuropsychological assessments. We hope to find whether there is a specific pattern of brain changes associated with prematurity that will help with early screening, diagnosis, and treatment of brain injury in prematurely born children as well as identify a connection between MR imaging and neurodevelopmental outcomes.</p>
Evaluating the Effect of a New Medication for Atopic Dermatitis
The purpose of the study is to evaluate if a new investigational medication, Tralokinumab, works for patients with atopic dermatitis (AD). Earlier studies of Tralokinumab have shown that the medication is effective in patients with AD. This study compares the effects of Tralokinumab to a placebo (no active medicine). To evaluate how well Tralokinumab works, we will perform a range of assessments to see how the severity of AD can decrease and quality of life could be improved.
Effect of Cold Stored Platelets to Slow or Stop Severe Internal Bleeding in Trauma Patients
<p style="text-align: center;"><span style="font-size: 18px;"><strong>Under the FDA rule Exception From Informed Consent (EFIC), severely injured patients taken to LAC+USC Medical Center with internal bleeding <u style="">may be enrolled into this clinical trial without their prior consent</u>. </strong><span style="font-size: 18px;"> </span></span></p><p style="text-align: left;">This site is to inform the public about this upcoming study and to give the public an opportunity to voice their opinion and/or to opt-out of the study in advance.</p><p style="text-align: left;"> </p><p style="text-align: center;">************</p><p style="text-align: left;">Trauma is the leading cause of death in people younger than 45 years. Unfortunately, 40-50% of severely injured patients with internal bleeding die, even after reaching the hospital. This clinical study is about whether Cold Stored Platelets can help slow or stop severe internal bleeding while the patient is being treated by the trauma team. </p><p style="text-align: left;">Platelet transfusions are a vital component of damage control resuscitation and are essential to blood clot formation and early stopping of severe bleeding. In usual care, platelets are stored in room temperature because they survive longer once infused into the body compared to cold-stored platelets. However, there are studies that suggest that cold-stored platelets can still be effective in early stopping of severe bleeding. This study is being done to see if giving Cold-Stored Platelets early in the course of treatment is feasible and if it would help improve outcomes in injured patients that lose a lot of blood.</p><p style="text-align: center;"><br></p><p style="text-align: center;">Scroll down to learn more.</p><p style="text-align: center;"> <br></p>
CD Flex: An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin (incobotulinumtoxinA) [Short Flex vs. Long Flex] in Subjects with Cervical Dystonia with < 10 Weeks of Benefit from OnabotulinumtoxinA Treatment MUS 60201 4073 1
Dystonia is a movement disorder characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures. Cervical dystonia (CD) is the most commonly described form of focal dystonia (abnormality involving a single area of the body). Xeomin (botulinum toxin type A), the study drug, has been shown to be effective and safe in the treatment of CD with two Phase III trials. Current practice in the treatment of CD with onabotulinumtoxinA (Botox) injection is to inject patients every 3 months. However, not all patients receive benefit from injections for the duration of 3 months. This study is designed to examine a shorter treatment interval with Xeomin injections and compare to the standard interval to determine if there is a difference from an efficacy standpoint (i.e., do the patients receive continuous benefit versus peaks and valleys) and if more frequent dosing leads to more development of botulinum toxin resistance. This study will evaluate if shorter dosing intervals is non-inferior to standard or longer dosing intervals by using the Toronto Western Spasmodic Torticollis Scale (TWSTRS) at control Visit 4 weeks post the the 8th injection. Secondary outcomes will evaluate efficacy, onset and offste of efficacy, safety and immunology. The primary efficacy variable will be defined as the change from study entry baseline in the TWSTRS-Severity score assessed at the 4-week control visti after the 8th injection (PPS sample). An analysis of covariance (ANCOVA) will be used for the primary efficacy analysis. All analysis of secondary endpoints for efficacy will be considered exploratory.
Help stroke survivors! Join research study on motion, balance and walking
<p> 85% of survivors of stroke experience walking issues, which limit their activities and participation. These issues include decreased coordination and slower walking, which might make people more prone to falls.</p><p> The objective of this study is to measure walking in people shortly after stroke and to identify which aspects of walking early after stroke indicate how well a patient recovers. Identifying these features will help physical therapists customize therapies to promote recovery of walking and help with other balance issues after a stroke. Therefore, we plan to test stroke survivors between 1-6 months after stroke and up to a year after they have suffered a stroke. </p>
All of Us Research Program
<p>The All of Us Research Program is a historic effort to gather information from one million or more people living in the United States. All of Us is a research program funded by the National Institutes of Health (NIH). The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.</p><p><br></p>
CHLA Research Study on Cerebrovascular Impact of Acquired Anemia
Anemia is a condition where the body is not making enough red blood cells to transport oxygen. The objective of this study is to learn how anemia may affect the oxygen delivery to the brain as measured by magnetic resonance imaging (MRI). By studying this, we hope to better identify people who may benefit from correction of their anemia.
Does pulling out work for birth control?
<p><strong>Why Withdrawal?</strong></p><p class="font_8">“Pulling out” or withdrawal is a method that people use to prevent pregnancy. It's been around for a long time and lots of people use it. However, we--scientists--STILL don't know very much about how to use it and how effective it really is. Some men have used withdrawal their whole lives without any unwanted pregnancies, whereas others have been less successful…</p><p class="font_8"><span style="font-weight: bold;">We want to know why!</span></p><p><strong>Our Questions:</strong></p><ul class="font_8"><li><p class="font_8">If withdrawal is used correctly, is there sperm released in the pre-ejaculatory fluid ("pre-ejaculatory fluid") that can make a woman pregnant?</p></li><li><p class="font_8">What makes someone more likely to have sperm in their pre-ejaculate?</p></li><li><p class="font_8">What affects whether someone will have sperm in their pre-ejaculate? Age? Experience? Sperm count? Something else?</p></li></ul>
Desarrollo del fetal saludable y placentario
¡Un recién nacido es un milagro! En el útero de la madre, muchos factores trabajan juntos para garantizar un desarrollo saludable del bebé. Los científicos y doctores de USC / Children's Hospital Los Angeles están tratando para comprender cómo el desarrollo de un bebé en el útero afecta su salud a lo largo de su vida. Esto nos ayuda a darles mejores terapias y tratamientos a los bebés con defectos de nacimiento para que puedan llevar una vida saludable.
Effect of ResQFoam to Slow or Stop Severe Internal Bleeding in Trauma Patients
Trauma is the leading cause of death in people younger than 45 years. Unfortunately, 40-50% of severely injured patients with internal bleeding die, even after reaching the hospital. This clinical study is about whether ResQFoam can help slow or stop severe internal bleeding in the abdomen (belly area) while the patient is being brought in for surgery. ResQFoam is a device that injects a liquid foam into the abdomen. The foam expands and forms a seal around the bleeding wounds, reducing blood loss.
Cognition as a moderator of motor learning post-stroke
The goal of this study is to understand how an individual’s cognitive function and brain structure may influence their ability to learn a new walking pattern. We hope to learn how people can best learn a new walking pattern when parts of the brain are damaged and cognitive function may be impaired.
Healthy Minds Volunteer Database
The Healthy Minds Volunteers (http://healthyminds.usc.edu) help research labs at the University of Southern California. These labs are working towards a greater understanding of how aging can affect physical, mental and emotional health. The goal is to learn how we can maintain healthy minds and bodies across our lifespan.
VNS Therapy for Treatment-Resistant Depression
The purpose of this study is to track active VNS Therapy treatment in subjects with Treatment-Resistant Depression (TRD) and to better understand the reduction in the severity of baseline TRD symptoms. Data will be collected on your responses to study treatments, quality of life, productivity, and your use of healthcare services. Your participation in this study will consist of evaluations by the study doctor (or his/her designee), who will review your past and current medical and psychiatric history, and several questionnaires which you will complete during several follow-up visits over time.
Recruiting | treatment resistant depression | Not Multisite
A pilot study of safety and efficacy of spectroscopic diagnosis of pancreatic lesions (Spy Panc)
The objective of this study is to determine if a minimally invasive optical probe can accurately predict a histological diagnosis of dysplastic or malignant tumor cells in solid lesions of the pancreas. If effective, this optical probe would facilitate the detection of malignant and pre-malignant pancreatic lesions. This would lead to more accurate decision-making as to which patients require surgical resection versus patients who should be spared from major surgery.
Diagnostic Fetal Imaging on a Novel MRI Scanner
We are seeking pregnant adults to participate in a study evaluating a novel, quieter MRI scanner. We hope to develop better ways for doctors to screen pregnancies for possible fetal problems and to make MRI of unborn babies more comfortable and even safer. Images will be collected at 3-6 fold lower magnetic field strength (0.55 Tesla) than a standard MRI. Participation in this study will involve being imaged on a lower field strength MRI scanner located in the Michelson Building at the USC University Park Campus. Participants will be compensated for their time.
A Placebo-controlled Study of a Targeted Immune Therapy Drug in Subjects with Moderate to Severe Ulcerative Colitis (UC)
The primary objective of this study is to study the effectiveness of a novel targeted immune therapy (biologic) called LY3074828 in treating moderate to severe ulcerative colitis. This study will take place over 120 weeks and all study visits and procedures will be provided at no cost to you. During the initial part of this study, patients will either receive LY3074828, or placebo ("dummy" treatment). Patients who receive placebo initially will have the opportunity to receive the study drug LY3074828 later in the study.
Long-Term Registry of Patients with Urea Cycle Disorders (UCDs)
The main goal of medical management of Urea Cycle Disorder (UCD) patients is to prevent chronic or acute hypperammonemic states leading to central nervous damage- which requires a restriction in dietary protein intake and using nitrogen scavenging agents if diet alone does not help the patients.The objective of this study is to characterize the demographic of the patient population diagnosed with UCD. Another objective is to track growth and neuro-cognitive outcomes for patients with UCDs. Patient participation includes the collection of retrospective and baseline data including ammonia and glutamine levels. Age appropriate questionaires will be given for completion by subject or parent. . Data will be collected on all individuals who are enrolled. The patient population are patients with an established or suspected diagnosis of UCD. The patient or legally acceptable representative must also sign and release an informed consent/HIPPA Authorization and medical records.The study procedures are for each study personnel to be trained for all documentation, baseline visits and enrollment for patients, and retrospective data for ammonia values obtained from the patient will be entered in the registry. The outcome variables will be the control of blood ammonia levels and the frequency of the serious adverse events (SAEs). Blood ammonium levels, and the frequency of hyperammonemic crisis will be observed during this study.The statistical analysis plan (SAP) will show details of all analysis and presentation of study data. Data will be shown to patients who attend the baseline visit, and analysis will be based on all the patients who are enrolled. Post baseline values or change from the baseline outcome variables will be summarized by UCD medication with statistics and graphical presentations.
The Medtronic CoreValve Evolut R US Clinical Study
Transcatheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centers treating patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement (SAVR). Medtronic has developed modifications to the Medtronic CoreValve System Transcatheter Aortic Valve frame and delivery catheter system to enable recapture of the device before it is fully released from the delivery system. These modifications are incorporated in the CoreValve Evolut R System.
The purpose of the study is to evaluate the safety and efficacy of the CoreValve Evolut R System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.
This is a prospective, single arm, historical controlled, multi-center study. This study will involve no more than 250 subjects in up to 25 sites. The study population includes males and females with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. Subjects will be followed up to 5 years following implantation.
Study endpoints are safety endpoints and efficacy endpoints. Safety endpoints are: All-cause mortality rate, stroke (disabling) rate, incidence of permanent pacemaker implant rate at 30 days. Efficacy endpoints are: Device success rate, Resheath and recapture success rate, percent of subjects with mild prosthetic regurgitation at early post-implant, hemodynamic performance metrics at 30 days.
Statistics/analysis: Subjects who are taken to the procedure room for implantation will comprise the study population evaluated for the study objectives and associated endpoints. An initial analysis will be performed when both of the following conditions are met:
1. The first 150 consecutive implanted subjects have completed their 30 day follow-up.
2. A total of 25 resheath or recapture attempts inclusive of all valve sizes, have been performed.
The final analysis will be performed after a minimum of 150 subjects but no greater than 250 subjects are implanted with the study device and followed for 5 years.
All endpoints are descriptive and no statistical hypothesis test will be performed.
Biobehavioral Mechanisms Underlying Eating Regulation and Obesity Risk
The goal of this study is to better understand how brain functioning relates to mood and eating behaviors in real life. You may be eligible if you experience binge eating or have difficulties controlling your eating behavior.
Diabetes Brain Study: A study to better understand the link between diabetes and brain health
Alzheimer’s disease is a brain disease that affects memory, thinking, and behavior, and causes severe memory loss over time, known as dementia. Diabetes increases the risk of developing Alzheimer’s disease and related dementias. Latinos have a higher risk of developing both diabetes and Alzheimer's but are underrepresented in research. We are studying the relationship between diabetes and brain health, and we hope to learn which diabetes-related brain measures best predict reduced brain function (cognitive decline). We want to improve prevention and treatment options for everyone.
New study at USC tests smartphone app to help older adults stay active. Join today!
<p>Engaging in even modest physical activity improves health and well-being, such as decreasing cholesterol and improving mood. However, despite the benefits of physical activity, less than 10% of older adults meet national physical activity guidelines. Health-related smartphone applications (apps) provide a promising approach to increase older individuals' physical activity. The purpose of this study is to develop, test, and refine a physical activity-tracking smartphone app that is designed to help older adults improve their physical activity by helping them overcome common barriers they may experience. For example, some older people might have low self-confidence or not know how to be more active. The app has a number of features to address issues like these. For instance, some users of the app will receive confidence-boosting messages about doing activity in older adulthood, whereas other users will receive tips throughout the day about how to break up how much time one spends sitting. </p><p> To participate in this study, we are looking for older adults (65–84 years of age) who own smartphones, reside in the Los Angeles area, and are not very physically active.</p>
Why do women use cannabis during pregnancy?
<p><strong>What does this study focus on?</strong></p><p>Cannabis is the most commonly used substance during pregnancy, yet little is known about why women use cannabis use during pregnancy.</p><p><strong>What is the goal of this study?</strong></p><p>The goal of this study is to talk and listen to Black, Indigenous, and People of Color (BIPOC) women who are using or have used cannabis during pregnancy to better understand: 1) their motivations for using cannabis during pregnancy, and 2) their use patterns during pregnancy.</p><p><strong>Why are we conducting this study?</strong></p><p>We hope to: 1) understand the barriers to receiving care facing BIPOC women who use cannabis during pregnancy, and 2) identify opportunities to improve public health knowledge around maternal cannabis use.</p>
S-ICD® System Post Approval Study
The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll
subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and
prospectively enroll new candidates for the S-ICD System. The target enrollment sample size
is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the
analysis cohort at 60 months.
- The primary safety endpoint of the study is the Type I (caused by the S-ICD System)
Complication Free Rate at 60 months compared to a performance goal of 85%.
- The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting
Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation
(VT/VF) through 60 months compared to a performance goal of 94%.
- The secondary safety endpoint of the study is the Electrode-Related Complication Free
Rate at 60 months compared to a performance goal of 92.5%.
- The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced
(Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a
performance goal of 84.0%.
Additional objectives include characterization of long term safety and effectiveness in
subjects of varied body habitus and in traditionally underrepresented populations.
Subjects must meet the following criteria to be eligible for inclusion in the study:
1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD
System in the S-ICD System Clinical Investigation (IDE G090013)
2. Willing and able to provide written informed consent or have informed consent provided
by a legal representative
Subjects who meet the following criteria must be excluded from the study:
1. Remaining life expectancy of less than 360 days
Enrolled subjects will be followed at the implant procedure, predischarge and annual(±60
days) follow-up visits. Subjects are followed according to the standard of care at their
participating investigational center.
The Genetics of Liver Fat (GoLF): Contributions of Genes and Liver Fat to Diabetes Risk in Mexican Americans
<p>Diabetes affects millions of people in the United States, and Latinos are at higher risk. The liver plays an important role in regulating blood sugar. At the University of Southern California (USC), we are seeking participants for an ongoing study to investigate how differences in your genes impact liver fat levels, and how these levels affect diabetes risk. We want to improve the understanding of diabetes, obesity, and fatty liver disease, and work toward developing better ways to treat and prevent these diseases. </p><p>This is a collaborative study between Kaiser Permanente Southern California (KPSC) and the University of Southern California (USC), sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).</p>
Study at USC tests smartphone app to help older adults with memory problems stay active. Join today!
<p> Despite the health benefits of physical activity, community-living older people with dementia have 26% lower physical activity levels than their cognitively healthy peers. Health-related smartphone applications (apps) are now frequently used to help people lead healthier lifestyles and provide a promising way to increase older adults' physical activity. Unfortunately, no physical activity apps exist that have been adapted for older persons with cognitive impairment despite that this group could benefit from such health-supportive tools. </p><p>The app-based intervention proposed for this study is named Moving Up-A. It includes features designed to assist older adults who have mild cognitive impairments become more physically active. The app provides users support to overcome common barriers to physical activity they may experience by increasing awareness about one’s physical activity patterns and by sending a variety of messages, tips, activities, and reminders. </p><p> To participate in this study, we are looking for older adults (65 years or older) who have difficulty with memory or thinking, who own smartphones, reside in the Los Angeles area or in the Pacific Time Zone, and are not very physically active.</p>
A novel, comprehensive approach to post-stroke gait rehabilitation
The purpose of this study is to understand how individuals control their walking after stroke while using visual information about their walking and while walking at different speeds. We hope to learn how people learn new walking patterns when parts of the brain are damaged and how this may change at different walking speeds.
Mother's Milk Study
The purpose of this study is to examine the effects of human milk oligosaccharides (i.e. HMOs, which are a type of sugar) on infant intestinal bacteria and understand how these sugars influence the growth and development of the child. The ultimate goal of this study is to promote the growth of good bacteria in the infant’s intestine and reduce the growth of harmful bacteria.
Lupus patients on Twitter: What do they think about using Twitter to engage them with their health?
It is estimated that at least 5 million Americans have the autoimmune disease lupus, with more than 16,000 new cases of lupus being reported annually in the U.S. Many patients take to Twitter to share their disease experience. With this study, we want to better understand Lupus patients who use Twitter and hear from them whether Twitter could be used as a tool to engage them with healthcare and research. This study is restricted to Lupus patients on Twitter who were contacted by the study team.
Tracking Obsessive-Compulsive Disorder (OCD) symptoms and predicting response to treatment using Fitbit, neuroimaging, and smartphone surveys.
<p>Obsessive-Compulsive Disorder (OCD) is a chronic, impairing disorder characterized by unwanted obsessions and/or compulsions. Not all persons with OCD are alike, resulting in a wide variety of symptoms, illness course, and response to treatment. The purpose of our OCD research study is to better understand differences in OCD symptoms and to predict both illness course and response to treatment. By comparing data from participants with OCD and healthy volunteers without OCD, we hope to provide enhanced treatments to future patients.</p>
Investigating efficacy and safety of adjunctive therapy in Parkinson’s Disease patients
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing of movements. Parkinson’s patients may have “on” periods where they are able to control their muscle movement, and “off” times when controlling these movements is harder.
Levodopa is a medication used to help treat Parkinson’s by increasing dopamine levels in the brain. We are looking for participants who have these “on” and “off” periods, and who are on Levodopa and at least one other medication. We are looking at whether adding tozadenant, a drug that hasn’t been approved by the U.S. FDA, will help improve Parkinson’s symptoms.
Recruiting | parkinsons adjunctive therapy | Not Multisite
Assessing the safety and efficacy of Macitentan in patients with portopulmonary hypertension
Several drugs (blood vessel dilators), including macitentan, are currently approved for the treatment of pulmonary arterial hypertension (PAH) in many parts of the world. These drugs have significantly improved the outcome of the condition. However, none of these treatments have been evaluated in portopulmonary hypertension, a form of PAH caused by liver disease. The purpose of this study is to assess the safety and effectiveness of macitentan in portopulmonary hypertension by looking at several clinical indicators, including the pressures within the arteries of the lungs and a person’s capacity for exercise.
Recruiting | High Blood Pressure / Hypertension | Not Multisite
VX-770 Expanded Access Program (EAP)
VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the
treatment of CF, is an orally bioavailable small molecule that targets the underlying defect
in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and
a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat
chloride concentration) and improvements in lung function were observed.
Patients who are interested in the VX-770 Expanded Access should contact their CF physician
about participation.
Physicians interested in participating as a site should contact 800-745-4484.
Approved for marketing | Cystic Fibrosis | Site Unknown
How does a stroke affect balance during walking?
<p>The purpose of this study is to understand how a stroke affects walking balance and why people post-stroke fall more frequently. Findings from this study could inform the design of rehabilitation interventions to improve post-stroke walking ability.</p><p><strong>We are looking for</strong> <strong>people who have had a stroke AND healthy adults who have not had a stroke. </strong>Participants will walk on a treadmill while experiencing trips that challenge balance, but a safety harness will be worn to prevent any falls.</p>
USC GeneScreen: The USC Alzheimer’s Prevention Registry
<p>Researchers at USC invite you, and your friends and family, to <u>enroll online</u> in USC GeneScreen, USC Alzheimer's Prevention Registry.</p><p>Alzheimer’s disease is a brain disease that affects memory, thinking, and behavior. It is a progressive brain disorder that causes severe memory loss over time, making it increasingly difficult for people to carry out daily activities. Alzheimer's disease impacts us all. </p><p> While valuable Alzheimer's research is being done every day to treat and prevent this disease, finding interested research participants remains an ongoing challenge. USC GeneScreen is a registry for people who are interested in participating in Alzheimer’s disease research studies at USC. By joining the registry, members are the first to hear about new and innovative studies that they may be eligible to participate in. </p>
A Phase III, Open-Label, Extension Trial of ECU-MG-301 to
Evaluate the Safety and Efficacy of Eculizumab in Subjects with Refractory Generalized
Myasthenia Gravis (gMG).
This is a phase III, open label, extension trial of ECU-MG-301(HS-13-00805) to evaluate the safety and efficacy of Eculizumab in subjects with refractory generalized myasthenia gravis (gMG). Eculizumab is a humanized monoclonal antibody that was derived from the murine anti-human C5 antibody m5G1.1. Myasthenia Gravis is a rare, debilitating, acquired autoimmune disease of the neuromuscular junction (NMJ), clinically characterized by weakness and fatigability of skeletal muscle. Since complement activation plays a pivotal role in the pathophysiology of MG, eculizumab, a terminal complement inhibitor, as such may benefit patients who continue to have generalized weakness and bulbar signs and symptoms despite current standard of care.
The primary objective of this trial is to evaluate the long-term safety of eculizumab in subjects with refractory gMG. Subjects who complete the 26-week treatment period (Visit 17) in the ECU-MG-301(HS-13-00805) trial may potentially enter this extension trial. There will be 3 periods in this study, Blind Induction Phase, Open-Label Maintenance Phase and Safety Follow-up Period. To preserve the blinded nature of the ECU-MG-301 trial, all subjects must undergo a blind induction phase and will receive blinded Investigational Product (IP) weekly for four (4) doses. Patients who were randomized to the placebo arm in the ECU-MG-301 trial will receive 4 vials IP (3 vials/900 mg eculizumab plus 1 vial placebo) at Visits 1 to 4. Patients who were randomized to the eculizumab arm in the ECU-MG-301 trial will continue to receive 4 vials IP (1200 mg eculizumab) every two weeks at Visits 1 and 3 and placebo at Visits 2 and 4. All subjects will receive open-label eculizumab (4 vials/1200 mg) every 2 weeks during the open level maintenance phase. On-Trial Rescue Therapy (high dose corticosteroid,plasmapheresis /plasma exchange (PE) or Intravenous Immunoglobulin,) will be allowed if a subject experiences clinical deterioration as defined in this protocol. For a subject who is discontinued from this trial, a follow-up visit for safety evaluation will be required. Primary efficacy endpoint is Safety and tolerability of eculizumab. Secondary Efficacy Endpoints will include the total change of QMG (Quantitative Myasthenia Gravis) score and total change of Myasthenia Gravis Composite (MGC) score. Safety analyses will be performed on the Safety Population and the Extension Safety Population includes all subjects who receive at least 1 dose of IP (eculizumab or Placebo). There is no interim analysis planned for this trial.
Enrolling by invitation | Myasthenia Gravis | Site Unknown
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of
osteorarthritis and degenerative disc disease. Anti-inflammatory components include
inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and
interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues,
including amniotic fluid, amniotic membrane and chorion are regulated as human cell and
tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft
materials for human injection. AlloGen-LI is derived from placental tissues obtained from
carefully screened healthy mothers at the time of scheduled cesarean section. The mothers
have agreed to donate the tissues, which would otherwise be discarded. The experimental
treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural
space under CT guidance, in an identical manner to traditional epidural steroid /marcaine
injections.
Enrolling by invitation | disc herniation | Not Multisite
Improving dermatologic care for psoriasis patients
We seek to evaluate an online psoriasis-care delivery model. Through this online model, patients can see the dermatologist online rather than coming into the office for a visit. The model is designed to increase patient and primary care physician access to dermatologists. We want to find out if this online model ultimately improves psoriasis severity and quality of life.
Tracking the Risk for Alzheimer’s Disease using the APT Webstudy
The Alzheimer Prevention Trials (APT) Webstudy is designed to accelerate enrollment into Alzheimer’s clinical trials by identifying and tracking individuals online, who may be at higher risk for developing Alzheimer’s. The Alzheimer’s Association estimates that 5.5 million Americans age 65 and older are currently living with Alzheimer’s dementia. It’s believed these numbers will increase by almost 30% to over 7 million people by 2025, where it’s the only top 10 cause of death that cannot be prevented, cured, or even slowed. The APT Webstudy is open to anyone over the age of 50. The goal of the APT Webstudy is to develop an online group of individuals who will allow their memory and thinking test scores to be tracked over time. Participants will have the opportunity to take online tests to assess their memory and thinking skills, gain access to their scores, and be notified of opportunities for in-person assessments and clinical trials aimed at preventing dementia. These in-person visits will be offered through the closest clinical site to participants.
Join today! New study at USC tests effectiveness of newly approved drug to help people with eczema, called Atopic Dermatitis
Atopic Dermatitis is a form of eczema that causes dry, scaly, itchy skin. More than 3 million cases are reported in the U.S. each year. People with this skin condition often have problems with bacterial skin infections caused by a specific bacteria known as, Staph aureus, or just Staph. Patients with chronic eczema often use long-term topical or oral treatments to help control their symptoms. But using these medications over long periods of time can have side effects on the body. The purpose of this study is to test the effectiveness of the drug dupilumab (dupixent), which was recently approved by the Food and Drug Administration (FDA) to offer relief to patients who cannot control their eczema with commonly used topical medications.We want to find out how dupilumab affects the amount of bacteria on the skin and the immune system of the patients, and whether it might cause less side effects. Join us today if you are between 18-65 years old with chronic eczema (Atopic Dermatitis).
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually
and despite effective antivirals causes significant morbidity and mortality (estimated
24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged
in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the
U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1
occurred among people younger than 65 years of age. The CDC has defined an at-risk
population that is responsible for the majority of hospitalization and morbidity associated
with influenza. This study will evaluate the use of combination antivirals as compared to
oseltamivir alone in the treatment of influenza in an at-risk population.
Subjects who meet the CDC definition for being at-risk and that present with an
influenza-like illness will be screened for the study. Those subjects with a confirmatory
test for influenza (rapid antigen or PCR) will be randomized in a 1:1 manner to receive a
blinded study treatment consisting of either the combination of amantadine, oseltamivir, and
ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments
on Days 1, 3, 7, 14, and 28 will be used for both safety and efficacy analysis.
Objectives:
- To evaluate the effectiveness of combined treatment with oseltamivir, amantadine, and
ribavirin compared with oseltamivir alone for at-risk individuals with confirmed influenza
infection.
Eligibility:
- Individuals at least 18 years of age who have one or more medical conditions that may
cause complications from influenza, and have developed an influenza-like illness.
Design:
- Participants will be screened with a physical examination and medical history, along
with blood tests and throat swabs to confirm influenza infection.
- Eligible participants will be randomly assigned to take either oseltamivir alone (the
current standard treatment for influenza) or to take oseltamivir, amantadine, and
ribavirin. Participants will have additional blood samples and throat swabs taken at
the start of the study, and will be shown how to complete a study diary at home.
- Participants will receive a study medication kit containing the medication to take at
home twice a day for 5 days.
- Participants will return, with the medication kit, to the clinic on days 1 (the first
day after the start of the study), 3, 7, 14, and 28. The first visit may take 2 to 3
hours, but each subsequent visit should take approximately 1 to 2 hours. Additional
blood samples and throat swabs will be taken at these visits.
Advancing Postmenopausal Preventive Therapy (APPT), a progestogen-free estrogen therapy to potentially reduce atherosclerosis: a randomized-controlled trial
<p> Cardiovascular disease (narrowed or blocked blood vessels) is the leading cause of death, killing 1 of every 2 women. Atherosclerosis (hardening of the arteries) is the major cause of cardiovascular disease. More than 90% of deaths due to atherosclerosis occur after menopause when a women’s production of estrogen disappears. Research over the last decade has shown that estrogen provides potential cardiovascular benefits with low-risk to women. However, most women have a uterus that requires co-treatment with a progestogen (Provera, progesterone, etc.) to prevent thickening of the uterine lining due to estrogen. Compared to estrogen-alone therapy, traditional progestogen-estrogen therapy appears to have a greater health risk for women. </p><p>The goal of this study is to learn whether a new type of progestogen-free hormone therapy, one that protects the uterus differently so that estrogen can be delivered without risk from progestogen, has beneficial effects on hardening of the arteries in postmenopausal women. Participants in the study will be randomized, split into two groups, to receive either an FDA-approved medication designed to deliver estrogen without a progestogen (Bazedoxifene /estrogen) or placebo, a pill that does not contain an active ingredient. </p>
0C-14-7: A Phase 1/2A, Multicenter, Open-Label Study of Oral RxDx-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations
RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor.
The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response (PR) at the recommended phase 2 dose of RXDX-101.
RXDX-101 is an orally available inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1, and ALK. Molecular alterations to these targets are present in several different tumor types, including non-small cell lung cancer, colorectal cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma.
The Phase 2a segment of this study will consist of 5 cohorts as described below:
Cohort #1: Participants that express TrkA. Cohort #2: Participants that express TrkB. Cohort #3: Participants that express TrkC. Cohort #4a: Participants that express ALK with an associated molecular alteration who are nave to prior treatment with ALK inhibitors. Cohort #4b: Participants that express ALK with an associated molecular alteration who have received prior treatment with one or more ALK inhibitors. Cohort #5: Participants that express ROS1
USC will only participate in Phase 2 of the study. The length of participation is about 2 months
An End of Treatment Visit will be conducted within 7 days of last dose of RXDX-101.
A Safety Follow-Up telephone call will be conducted approximately 30 days following the last dose of RXDX-101.
Primary endpoint will be first cycle dose limiting toxicities and maximum tolerated dose
The baseline, clinical outcome, laboratory, PK, and safety data from both segments of the study will be analyzed descriptively
Study at USC is developing active sitting technology. Join today!
<p> Older adults can spend nearly 80% of their day sitting, doing sedentary activities such as watching TV, reading, and using the computer. FitSitt is an innovative device tailored to older adults and designed to improve health by increasing the convenience of breaking up sedentariness and incorporating movement into in-home daily routines. Whereas many interventions aim to increase physical activity by focusing on dedicated exercise sessions such as daily workouts, research suggests that key improvements to health can occur when regular movement is woven into the day, thereby reducing long inactive periods. </p><p> The purpose of this study is to refine and tailor a working prototype of FitSitt, and test the system to see if it is feasible to use and acceptable to older adults. This project will ultimately help the development of an optimized, in-home, comprehensive sedentary activity solution for older adults and countless other populations that could benefit from reducing the deleterious health effects of extended inactive behavior through convenient and comfortable-to-use intervention. </p>
Not yet recruiting | sedentary activity | Not Multisite
Effect of Corneal Preservation Time on Long-Term Graft Success
When the donor cornea is removed from the person who died, it is prepared for
transplantation by an eye bank. The donor cornea is placed into a liquid that helps
preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has
approved storage of the cornea in this liquid for up to 14 days before the transplant. The
purpose of this study is to see if the length of time the donor cornea is kept in the
preservation liquid before the transplant affects the likelihood of the transplant being
successful. We will follow participants for 3 years after transplant to see if there are any
differences in transplant success or in the number of transplanted endothelial cells (the
layer of cells that line the undersurface of the cornea) on the corneas that were preserved
for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to
believe that there is any greater risk for transplant failure with either preservation time
group.
Eisenmenger Quality Enhancement Research Initiative
Approximately 200 male and female adult patients with a history of Eisenmenger will be
recruited from approximately 50 cardiology practices over a period of 18 months and will be
followed up every six months for the period of three years. Consecutive patients in each
practice meeting inclusion and exclusion criteria should be considered for the study.
Participating sites will be asked to maintain a screening log to identify which inclusion or
exclusion criteria was not met thus excluding them from the study.
A Phase 3, Randomized, Double Blind, Placebo And Active‑Controlled, Multicenter, Parallel‑Group Study Of The Analgesic Efficacy And Safety Of Tanezumab In Adult Subjects With Chronic Low Back Pain
This is a randomized, double blind, placebo and active controlled, multicenter, parallel
group Phase 3 study of the efficacy and safety of tanezumab when administered by SC
injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800
subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects
per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and
600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo
administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At
the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be
switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg
administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56;
2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to
Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching
tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week
interval to Week 56. The study is designed with a total duration (post randomization) of up
to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days;
includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment
Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and
Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37
days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and
an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to
entering the study, subjects must have a documented history of previous inadequate treatment
response to medications in 3 different categories of agents commonly used to treat and
generally considered effective for the treatment of chronic low back pain.
Beta Cell Restoration Through Fat Mitigation
BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin
over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The
primary outcome will be change in β-cell compensation for insulin resistance, which the
investigators will compare between groups. Secondary analyses will include other potential
markers of β-cell health and potential mediators of treatment-specific effects. The main
focus will be on mediators related to obesity. Clinically, the project will serve as a test
of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell
disease. Biologically, the results will provide crucial information on potential mediators
of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will
guide the development of more effective treatment and monitoring for the β-cell disease that
causes type 2 diabetes.
A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir, in Orthotopic Liver Transplant Recipients
End stage liver disease secondary to Hepatitis C virus infection is the most frequent indication for liver transplantation. However, recurrence of the disease is almost universal and is the cause of increased morbidity and mortality. At this time, attempts to treat recurrence have been difficult as the treatment is difficult to tolerate and often ineffective in the post transplant setting. In this study, we hope to learn if treatment with hepatitis C immunoglobulin (Civacir) post-operatively is safe and effective in the prevention of disease recurrence. Participants will be randomized 1:1 to 300mg/kg or control. Participants will be followed out to 6 months with monitoring of hepatic function and HCV levels. Safety data will be collected through medical follow up, examinations and follow up of hepatic function. Statistical analysis will be conducted by the sponsor to determine if the drug (and dose) are effective in preventing recurrent HCV.
Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
The purpose of this study is to evaluate the safety and effectiveness of the leadless
pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The
Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in
battery and electrodes, for permanent implantation in the right ventricle. As a leadless
pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has
the same operating principles as a conventional pacemaker.
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the
anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from
other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it
is the most common form of uveitis and accounts for approximately 75% of cases.
In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone
phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects
with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437
treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without
requiring additional treatment; produced low short-term systemic exposure to dexamethasone
and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8
mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid
mediated effects were observed.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The
study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0
mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis
with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone
acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.
CardioMEMSTM HF System Post Approval Study
RATIONALE: Heart failure is a major cause of morbidity and mortality. CardioMEMS HF System is an FDA approved implantable device that wirelessly measures and monitors pulmonary arterial pressure and heart rate. The CHAMPION trial demonstrated that management of heart failure using pulmonary artery pressure information obtained with the CardioMEMS HF System, in addition to traditional signs and symptoms, reduced HF hospitalizations.
INTERVENTION: Patients will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
OBJECTIVES: The objective of this study is to confirm the post-market safety and effectiveness of the CardioMEMS HF System to premarket.
STUDY POPULATION: Twelve hundred subjects will be enrolled with at least 35% of the enrolled patients being women (420 women out of 1200). Enrollment will be limited to 15% of the total study population at any one site.
STUDY METHODOLOGY: This is a prospective, multi-center, open-label trial conducted in the United States (US). All subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the CardioMEMS HF System PAS and will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
STUDY ENDPOINTS:Primary safety endpoints will be evaluated at 2 years: 1) freedom from device/system related complications and 2) freedom from pressure sensor failure.
STATISTICS: The primary safety hypotheses are that the device / system-related complication-free proportion of subjects will be at least 80% at 24 months (OPC used in the CHAMPION trial) and that the pressure sensor failure-free proportion of subjects will be at least 90% at 24 months (OPC used in the CHAMPION trial). Plotting and analysis of safety endpoints will also be displayed using Kaplan-Meier methods. All safety analyses will be performed on the safety population.
Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients With Comorbid Autoimmune Conditions
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than
400,000 individuals in the United States, and 2.5 million worldwide
(www.nationalmssociety.org). The main pathogenic mechanism in MS involves an inflammatory
condition that damages the myelin of the central nervous system (CNS), resulting in axonal
damage and neurological impairment, often leading to severe disability. MS is one of the
most common causes of neurological disability in young and middle-aged adult individuals,
and as such has a tremendous physical, psychological and social impact on patients' lives.
MS is a complex disease diagnosed by McDonald criteria with different clinical and
pathological phenotypes. Several forms of MS have been described: Relapsing-Remitting
(RRMS), Secondary-Progressive MS (SPMS), Progressive-Relapsing MS (PRMS), and
Primary-Progressive MS (PPMS).
Glatiramer Acetate (GA) and Beta-Interferons (β-IFNs) are well established first-line
immunomodulating treatment options for relapsing remitting multiple sclerosis (RRMS) with
excellent safety profiles. The mechanisms of action of GA and IFNs are different. It is well
known that in general Disease-Modifying Treatments (DMTs) reduce relapse rate in more than
half of the multiple sclerosis (MS) patients who receive DMT, while having little if any
effect on the rest. It has been speculated that the response to beta-interferons or GA may
have genetic basis. As Axtell RC et al. indicated the experimental autoimmune
encephalomyeilits (EAE) in mouse caused by TH1 cells generally respond well to
interferon-beta, while EAE caused by TH17 cells get worse with interferon-beta.
Autoimmune disease is an extreme situation where the autoimmune response overshoots and goes
out of control. The other extreme is a degenerative disorder, where the autoimmune response
is not strong enough for effective protection, and degeneration therefore continues. GA
being an immunomodulator may provide both properly regulated immune suppression (in the case
of autoimmune disease) and properly regulated immune activation (in the case of the
neurodegenerative disease).
Autoimmune conditions cluster in families with high risk for multiple sclerosis than in
general population which suggests that the disease might arise on a background of a
generalized susceptibility to autoimmunity. Occurrence of psoriasis, autoimmune thyroiditis,
vasculitis, rheumatoid arthritis, scleroderma, lupus are seen more commonly in MS patients.
Many of these patients initially get started on beta-IFNs, and usually do not do well on
them. According to Investigator's and the USC MS Comprehensive Care Center experience,
autoimmune co-morbidity associated with MS can serve as a biological marker predicting good
response to GA and unfavorable response to the IFNs.
Nattokinase Atherothrombotic Prevention Study
Objectives and Hypotheses: The goal of the proposed study is to determine under randomized
controlled trial (RCT) conditions whether nattokinase reduces subclinical atherosclerosis
and cognitive decline in healthy women and men. The investigators' hypotheses are: 1)
Compared to placebo, nattokinase will show less subclinical atherosclerosis progression and
cognitive decline in healthy women and men; 2) The reduction in subclinical atherosclerosis
progression and cognitive decline with nattokinase will be correlated; and, 3) The reduction
in progression of subclinical atherosclerosis and cognitive decline with nattokinase will be
mediated through hemostatic, fibrinolytic and hemorheological factors as well as attenuation
of inflammation, monocyte activation, vascular endothelium injury and activation of vascular
endothelium by circulating monocytes.
Specific Aims: To conduct a RCT to determine the effect of nattokinase on the progression of
subclinical atherosclerosis (primary trial end point) and cognitive decline (secondary trial
end point). Healthy non-demented women and men >55 years old without pre-existing
symptomatic CVD and diabetes mellitus will be randomized over a 2 year period to oral
nattokinase (2,000 fibrinolysis units) daily versus placebo in this double-blind,
placebo-controlled trial; randomized treatment will be 3-years. The following 5 major
specific aims will be completed:
1. To determine the effect of nattokinase on the progression of subclinical carotid artery
atherosclerosis determined as the rate of change of the common carotid artery
intima-media thickness (CIMT) and arterial stiffness in computer image processed B-mode
ultrasonograms.
2. To determine the effect of nattokinase on cognitive decline determined with a
neuropsychological battery designed to evaluate 7 cognitive domains including:
attention, concentration, working memory, executive function;
visuospatial/visuoconstructive skills; naming/semantic memory; and verbal and nonverbal
episodic memory.
2a. To determine the effect of nattokinase on cognitive decline according to apolipoprotein
(Apo) E e4 genotype.
3. To determine the association of subclinical atherosclerosis progression with cognitive
decline.
4. To determine whether the effects of nattokinase on subclinical atherosclerosis and
cognitive decline are mediated through hemostatic (fibrinogen, factor VIII, platelet
activity), fibrinolytic (tPA, PAI-1, D-dimer), hemorheological (plasma and blood viscosity,
red blood cell aggregation) and inflammatory (MCP-1, IL-8, TNFα, IL-1β, IL-10, monocyte cell
surface markers CD11b/CD11c and VLA-4, expression of adhesion molecules VCAM-1 and ICAM-1 in
cultured human aortic endothelial cells) factors as well as blood pressure.
Not yet recruiting | Atherosclerosis | Not Multisite
Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program
This is a prospective, U.S.-based, multi-center, knowledge translation program tracking patient management until approximately early 2018. To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC). The goal of the optimal functional class is to improve WHO functional class III and IV patients to functional class I or II, and to improve all functional class II patients to functional class I, or at least to maintain functional class I/II in patients presenting in that functional class. Endpoints:1. Proportion of patients achieving guideline-recommended treatment at each documented visit.2. Proportion of patients achieving optimal functional class using an evidence-based reatment algorithm.3. Proportion of patients on various therapies in relation to their WHO functional class.4. PAH management (use of therapies) by physicians across patient risk strata based on FC.5. Association between treatment and physician and patient adherence with recommended treatment.6. Utilization of Knowledge Translation Program system reminders, and response by the physicians when asked for reasons evidence based therapy was not utilized.7. Survival by FC (baseline and change), etiology, prevalent vs incident, academic vs community, adherence and reminders.Descriptive analysis of demographic variables, physical exam, medical history and treatment profile will be performed as appropriate. Confidence Intervals (95%) will be calculated for descriptive and comparative purposes.
Not recruiting | High Blood Pressure / Hypertension | Site Unknown
Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms
The primary objective of this study is to determine the success of Gilenya® (fingolimod)
treatment in patients with MS of Hispanic descent relative to their ancestral background.
Therapeutic success will be determined by annualized relapse rate (ARR; defined as the
number of relapses divided by the person years followed) after initiation of treatment with
Gilenya® (fingolimod)in comparison to the relapse rate in the previous 12 months. This will
be determined based on medical chart extraction, in-person assessment and regular clinical
follow-up.
A secondary objective of this study is to investigate whether the efficacy of Gilenya®
(fingolimod) is superior or equal in HW which have higher loads of Amerindian versus
Caucasian background with opticospinal MS (OSMS-NMO neg) versus classical MS (CMS) in the
first 12 months using radiological and clinical parameters. The following measures will be
obtained:
1. Number of relapse-free patients over the investigational period
2. Site of relapse defined as brain or spinal cord.
3. Sustained Disability progression will be defined as a one point (1) increase from
baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5)
increase in patients with baseline EDSS score of 5-5.5 or above after 3 months.
4. MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions
after 12 months from baseline.
Unknown status | Multiple Sclerosis | Not Multisite
A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group,
3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on
Therapy to Insulin in the Treatment of Subjects with Type 1 Diabetes Mellitus
Canagliflozin (CANA) is an oral antihyperglycemic agent (AHA) approved for the treatment of subjects with Type 2 Diabetes Mellitus (T2DM). In subjects with T2DM, CANA lowers blood glucose by an insulin-independent mechanism and has an intrinsic low risk of hypoglycemia. In subjects with T1DM the addition of CANA to intensive insulin therapy is expected to lead to less insulin requirement which is expected to lead to a reduced insulin dose requirement, weight gain, glucose variability and low the risk of hypoglycemia. The primary objective of this study is to assess the effect of CANA 100 mg and 300 mg compared with placebo on the change in HbA1c and body weight after 18 weeks of treatment. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, interventional study of CANA in male and female subjects between the ages of 25 years to 65 years, inclusive, with a diagnosis of T1DM for at least 1 year, and inadequate glycemic control (ie, HbA1c of 7.0% to 9.0%) on basal plus bolus insulin at screening. Approximately 330 subjects will be randomly assigned in this study (20 at the USC site), with approximately 110 subjects randomized per treatment group. The primary hypothesis will be assessed using a composite primary endpoint: proportion of subjects with HbA1c reduction 0.4% and no increase in body weight. Assuming the proportion of subjects meeting the composite criteria is 20% for placebo and 40% for each CANA dose, and assuming a 2-sided family-wise Type I error rate of 0.05, it is estimated that a sample size of 100 randomized subjects per group will be required to achieve 84% power for the comparison of each CANA dose to placebo. A modestly larger sample size (110 subjects per arm) will be randomized to each treatment arm. The modified intent-to-treat (mITT) analysis set includes all randomized subjects who have received at least 1 dose of double-blind study medication. The per-protocol (PP) analysis set consists of all mITT subjects who complete the 18-week double-blind treatment phase, and have no major protocol deviations that may affect the interpretation of the primary efficacy endpoint. The completers analysis set consists of all mITT subjects who complete the 18-week double blind treatment period. The primary efficacy endpoint will be proportion of subjects with HbA1c reduction 0.4% and no increase in body weight after 18 weeks of treatment. The primary efficacy endpoint will be analyzed longitudinally using a generalized linear mixed model. The model will include the fixed, categorical effects of treatment, stratification factor (use of CSII vs MDI), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline body weight, and baseline-by-visit interactions. An unstructured covariance will be used to model the within-patient errors. The odds ratio and 2-sided 95% confidence interval (CI) for the treatment comparison at Week 18 (CANA vs placebo) will be estimated based on this model. As a sensitivity analysis, the last-observation-carried-forward method will be applied when the Week 18 values are missing. The odds ratio will be assessed by a logistic regression model with terms for baseline HbA1c, baseline body weight, treatment and stratification factor.
A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Multiple studies have demonstrated the positive effect of early therapy on patients who were in the earliest stages of relapsing-remitting multiple sclerosis (RRMS; having 1 clinical event clinically isolated syndrome [CIS] and magnetic resonance images [MRIs] suggestive of MS). These studies involved partially effective medications, all with approximately a 30% reduction in relapse rate.Tysabri is a monoclonal antibody that binds and interferes with the action of 41 integrin which results in reducing certain cells of the immune system transmigration across the blood brain barrier.In the recently presented Tysabri Observational Program (TOP) data, early treatment was most effective in treatment-nave patients and patients with lower Expanded Disability Status Scale (EDSS) scores. Thus, use of an effective agent (Tysabri) in the early stages of MS (when immune cell collections have not yet developed behind the blood-brain barrier [BBB]) may be beneficial, and has not been systematically studied.Study population includes RRMS patients diagnosed with Mc Donald's Criteria, Age 18 to 45 years old, Anti-JCV antibody negative test within 6 months of Screening Visit or negative test for anti-JCV antibody at Baseline Visit.Methodology:This is a Phase 4, single-country, multicenter, open-label, prospective, observational study.The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The response factors include clinical assessments of sustained EDSS progression, relapse status, and MRI measures, and patient reported outcomes (PROs) of cognition, capacity to work, quality of life (QoL), and visual function assessments.In general, continuous variables will be presented with summary statistics (mean, standard deviation, median, range), and categorical variables will be presented with frequency distributions. All analyses will be conducted using 2-sided tests at the type I error rate (alpha level) of 0.05 unless otherwise stated.There will be up to 10 clinic visits included in this protocol. A patients participation in the study will last up to 48 months.
A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin FlexPro in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period
Rationale: The aim of the project is to develop a long-acting once-weekly GH product which is a safe and efficacious but has greater convenience and thus potentially better compliance compared to standard once daily GH treatment.
Intervention: Subjects will receive subcutaneous injection of study drug ( NNC0195-0092, Norditropin FlexPro or placebo. ) and being monitored efficacy and safety with AE, MRI, DEXA scan, Vital signs, Hts and weights, Hematology, Biochemistry, thyroid function, Hormones ,ECG and Eye exams.
Objectives or purpose: The primary objective is to access the efficacy and the secondary objective is to evaluate the clinical safety.
Study population or sample characteristics: This study is aiming for subjects who is between age of 23-79 with diagnosis of GHD who has no history of or active malignant disease.
Study methodology: Two hundred and eighty will be randomized in a 2:2:1 (NNC0195-0092: Norditropin FlexPro: placebo) ratio. The trial will compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily dosing of Norditropin FlexPro in adults with GHDs during the 35-week period (8 week dose titration, 26 week fixed dose treatment followed by 1 week washout), with a 53-week extension period (8 week dose titration, 44 week fixed dose treatment followed by 1 week washout). After the main trial period placebo subjects will be switched to NNC0195-0092 treatment and Norditropin FlexPro subjects will be randomised 1:1 to NNC0195-0092 or Norditropin FlexPro.
Study endpoints or outcomes: The primary endpoint will be at week 34 for the main trial and the secondary endpoint will be at 86 weeks for the extension period of trial. The study is looking for the outcome of changing in truncal fat mass and truncal lean body mass after the treatment, as well as to evaluate the safety of this drug.
Follow-up: Follow up visit will be scheduled 2 weeks after last treatment.
Statistics and plans for analysis: For each of the complete data sets, the change from baseline to 34 weeks is analysed using an ANCOVA model with treatment, GHD onset type, sex, region, DM and sex by region by DMinteraction as factors and the baseline truncal fat value as a covariate. From the pooled estimates, the treatment difference at Week 34 between NNC0195-0092 and placebo willbe estimated and the corresponding 95% CI and p-value will be calculated.Superiority of NNC0195-0092 over placebo will be considered confirmed if the upper boundary of
the two-sided 95% CI of the treatment difference (NNC0195-0092 placebo) is below 0. Sensitivity analysis will also be completed. Two partial database locks are planned during the trial.
Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
This study is a prospective, randomized, multi-center study, intended to evaluate the
outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The
study is designed to compare the anatomically stabilized AFX Endograft System to a reference
group of proximally fixated EVAR devices. Patients will be randomized between the two
groups.
Randomization will be 1:1. Each investigator will select one comparator device of their
choice before enrolling the first patient. The study will sequentially evaluate
non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this
study.
A PHASE IIIb, MULTICENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF DYSPORT USING 2 mL DILUTION IN ADULTS WITH CERVICAL DYSTONIA A-TL-52120-169
A multicentre, randomised, double blind, placebo controlled study where at study entry, subjects will be randomised in a ratio of 2:1 to receive either Dysport or placebo. The primary objective of the study is to evaluate the efficacy and safety of Dysport 500 units (U)/vial using 2 mL dilution compared with placebo for the treatment of cervical dystonia (CD). All subjects are planned to have a single treatment in this study. Following study treatment, follow up visits will be performed at Week 2, Week 4 and Week 12 (+28 days/4 weeks) or early withdrawal due to any reason. All subjects who complete the Week 12 visit will be considered to have completed the study and will be offered entry into an open label extension (OLE) study, which consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Between Weeks 4 and 8, subjects may be deemed eligible for early entry into the OLE study, i.e. before they reach the planned Week 12 study visit if rescue treatment is needed. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from baseline in TWSTRS total score at Week 4. Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. Therefore, in this clinical study the majority of enrolled subjects will be previously treated with Botox to reflect the real world clinical scenario in the USA.Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS. Exploratory analysis will be performed for each of the tertiary secondary efficacy endpoints using appropriate methods.
A Phase 3b, Prospective, Multicenter, Open-Label Extension Study to Assess Long Term Safety and Efficacy of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia
A phase 3b, prospective, multicenter, open-label extension study to assess the long term safety and effectiveness of Dysport using 2 mL dilution in adults with cervical dystonia. This study is open to subjects who have completed the Dysport double-blind study protocol A-TL-52120-169 or are eligible for early entry, from enrollment into the 169 study.Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. The primary objective of the study is to assess long term safety of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). Secondary objective is to assess long term efficacy of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). The study consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from treatment cycle baseline (defined as Day 1 in each cycle) in TWSTRS total score at Week 4 and Week 12 visits, in Treatment Cycles 1, 2, and 3. Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS.
CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
A total of 400 HIV-uninfected men who have sex with men (MSM)and male to female (M to F)
transgender individuals with recent high-risk transmission behavior will be enrolled into
the study. Each subject will be followed for up to 48 weeks after enrollment of the last
subject. The primary endpoint will be measured at 48 weeks.
All subjects will start PrEP with TDF + FTC fixed dose combination given once daily.
Subjects will be randomized (1:1) to either the iTAB text messaging adherence reminder
intervention with SoC or the SoC alone arm. Subjects placed into the iTAB intervention arm
will receive a personalized, automated texting system to maintain adherence and retention.
Both groups will receive access to PrEP in accordance with standardized comprehensive
methods of prescribing, risk reduction counseling, adherence counseling, and clinical
assessments that include safety monitoring, as well as HIV and STD screening.
TDF 300 mg + FTC 200 mg fixed dose combination will be given orally once daily starting at
the baseline visit (month 0) and continued throughout the study.
Assessing brain response to sugar
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
A Phase 3, Long-Term, Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses
of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary
goal is to determine the long-term safety and tolerability of MYOBLOC (administered
intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a
maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The
secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered
intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments
performed at intervals after treatments every 13 weeks over a maximum possible duration of 1
year.
Join a USC Study on Mood and Smoking
<p> Depression may increase smoking dependence and might make it harder to quit. We want to better understand the connection to develop better programs that help smokers to quit. You do <strong>NOT </strong>need to be diagnosed with depression to participate in this study. </p><p> For this study, participation involves taking surveys on a mobile phone or other compliant smart device, completing questionnaires online, and completing interviews via video chat and phone.</p>
Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs a colonoscopy instead of referring 100% of their patients simply because they turn 50 years old.
7H-14-1 An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Head and neck carcinomas (HNC) describe cancers of the upper digestive tract which include squamous cell cancers (SCCHN) of the mouth, throat, and vocal chords. At present, there is no effective standard of care that provides survival benefits beyond 4 - 6 months in second line treatment of SCCHN that spreads or returns and does not respond to platinum treatment (refractory). Nivolumab is a drug that binds to a tumor cell receptor that blocks the immune system, thus allowing the immune system to attack tumor cells. Nivolumab has demonstrated clinical activity across several tumor types, but there has been no clinical trial so far to study the clinical benefit of nivolumab in SCCHN. Cetuximab, methotrexate, and docetaxel, which appear to be the most active in the platinum refractory setting, have approved indications as single agents for treating SCCHN and will be used as the Investigator's Choice in this study. The objective of this study is to compare progression free survival (PFS) and overall survival (OS) of Nivolumab to Investigators Choice in subjects who have tumor progression within 6 months of last dose of platinum therapy.
Patients who will be enrolled for this study will have laboratory confirmed SCCHN whose disease has spread or returned within 6 months of being treated with a platinum based therapy. Participants will be randomized to receive one of the following: nivolumab, cetuximab, methotrexate, or docetaxel. During the study, participants in all groups will have the study procedures done during each cycle as stated in the protocol. All participants will stop taking study drug(s) if their disease worsens, they have another illness which prevents them from taking the study drug(s), they cannot tolerate the side effects, they withdraw from the study, their study doctor thinks that being on the study is no longer in their best interest, or the sponsor stops the study. All participants will be followed for 35 days and 80 days after stopping the study drug(s), and then every 3 months until death.
Subject characteristics including demographics, baseline performance status, disease
characteristics and baseline laboratory parameters will be summarized by randomized treatment
arm, as well as pooled across randomized treatment arm. A two-sided 0.03 log-rank test will be used to do a formal comparison of PFS across all treatment arms. Median PFS will be estimated via the Kaplan-Meier product limit method. Two-sided 95% confidence intervals (CI) for the median PFS will be computed for each randomized arm. Kaplan-Meier plots of PFS will be presented. Hazard ratios (HR) and corresponding two-sided (1-adjusted )% CI will be estimated using a Cox proportional hazards model, with treatment arm as a single covariate, stratified by the above factor, corresponding to each comparison of PFS. OS will be compared between the treatment arms among all randomized subjects using a two sided, = 0.02 level log-rank test (adjusted for interim analysis), stratified using the same factor as in PFS.
Evaluating the Efficacy of a New Medication for Hidradenitis Suppurativa
The purpose of the study is to evaluate if a new investigational medication, Bimekizumab, works for patients with hidradenitis suppurativa (HS). Earlier studies of Bimekizumab have shown that the medication is effective in patients with HS. This study compares the effects of Bimekizumab to an FDA-approved medicine, Adalimumab, and a placebo (no active medicine). To evaluate how well Bimekiumab works, we will perform a range of assessments to see how the severity of HS can decrease and quality of life could be improved.
A Multicentre Phase II Study of AZD1775 Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a phase II study of AZD1775 plus chemotherapy in patients with platinum-resistant
epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive
AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary
endpoint for the study is overall response rate (ORR) defined as the proportion of patients
achieving a complete or partial tumour response according to Response Evaluation Criteria in
Solid Tumours (RECIST) v1.1. Secondary endpoints include assessment of the duration of
response (DoR), overall survival (OS), progression-free survival (PFS), disease control rate
(DCR), Gynecologic Cancer Intergroup (GCIG) cancer antigen-125 response, safety and
tolerability, clinically significant changes in safety-related laboratory parameters,
pharmacokinetics (PK) and drug-drug interactions of AZD1775 plus carboplatin and AZD1775
plus PLD.
Six (6) patients will be enrolled in the AZD1775 plus carboplatin arm (designated Arm C) in
a dose escalation scheme as a safety lead-in cohort. When a safe and tolerable dose of
AZD1775 in combination with carboplatin is determined, 17 additional patients will be
enrolled to be treated at that dose level. Patients may continue on study as long as they
are benefitting, have no evidence of disease progression, and do not meet any criteria for
discontinuation or withdrawal.
Up to 12 patients will be enrolled in the AZD1775 plus PLD arm (designated Arm D) in a dose
escalation scheme as a safety lead-in cohort. When a safe and tolerable dose of AZD1775 in
combination with PLD is determined, 17 additional patients will be enrolled to be treated at
that dose level. Patients may continue on study as long as they are benefitting, have no
evidence of disease progression, and do not meet any criteria for discontinuation or
withdrawal.
A Safety Review Team (SRT) will assess the safety and tolerability of the first 6 patients
in each arm by incidence and severity of adverse events (AEs) after a minimum of 1 treatment
cycle as determined by NCI CTCAE v4.03 and the occurrence of pre-defined dose-limiting
toxicities (DLTs). Patients must complete Cycle 1 safety evaluations, and return to the
study centre for Cycle 2 Day 1 evaluations to be considered evaluable for the safety
lead-in.
Once the AZD1775 plus carboplatin (Arm C) and AZD1775 plus PLD (Arm D) arms are evaluated as
safe and tolerated by the SRT, these arms will continue enrolling until 23 patients have
been evaluated for efficacy (i.e., tumour response).
Assessing the Efficacy of Secukinumab in Psoriasis Patients
The purpose of the study is to see if secukinumab has an effect on fatty tissue beneath the skin and on skin inflammation in patients with psoriasis. This study will also look at blood tests, or “markers,” that could help identify risk for heart disease and metabolic diseases like diabetes or cardiometabolic disease. Secukinumab (Cosentyx®) is a prescription medicine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis in adults.
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with
the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of
five years.
2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel synthetic small molecule that binds to the adenosine triphosphate (ATP) pocket in the N-terminus of Hsp90 and demonstrates significant activity for down-regulating Hsp90 client protein levels. This ability to impact a broad array of important oncogenes and cell signaling kinases is reflected in ganetespibs activity across a wide variety of tumor cell types.Patients will be randomized in a 1:1 ratio to receive either ganetespib in combination with docetaxel or docetaxel alone. The study will enroll approximately 500 patients, 12 from USC, over a planned 12-month period, and patients will be randomized into one of two treatment arms.
An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)
VTI-212 is an open-label, multicenter, historically-controlled study of subjects with acute
liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the
study will receive ELAD treatment in addition to standard of care treatment for ALF. The
outcomes of these subjects will be compared with matched historical controls drawn from
existing databases.
Subjects will undergo ELAD treatment for a minimum of 3 days (72 hours). It is recommended
ELAD treatment be continued up to 10 days (240 hours).
Following ELAD treatment, subjects will continue standard medical therapy as defined by the
institution and be followed through Study Day 28.
Subjects' diagnosis of ALF will be attributed to one of the following:
1. FHF (acute liver failure with no preexisting liver disease);
2. Primary Graft Non-Function (PNF);
3. Surgically-Induced Liver Failure (including subjects with small for size liver
transplants, living donor liver transplants, and subjects with risk of ALF following
liver cancer surgery.
Screening evaluations and assessments will be completed for subjects and reviewed against
inclusion/exclusion criteria.
Enrollment will define the time of study entry (Hour 0, Study Day 1, study baseline) and
inclusion in the ITT population. Subjects will be evaluated throughout the 28-day study
period.
If standard medical therapy, as defined by the institution and this protocol is consistent
with discharging the subject home, then the subject should be discharged. Prior to
discharge, the subject will be advised to attend all follow-up visits.
An extension of this study, VTI-212E, will provide additional ELAD survival data, as
available, through VTI-212 study termination (after the last surviving enrolled ELAD subject
completes Study Day 28). This registry protocol segment of VTI-212 extends the safety
monitoring period to 5 years to assess survival, incidence and characterization of tumor (in
particular hepatocellular tumor), incidence of liver transplant, and assess quality of life
using a standard, validated questionnaire.
Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links with Clinical Outcomes
Observational study to collect F/U imaging & clinical endpoint data from pts. who successfully completed baseline coronary IVUS (intravascular ultrasound) imaging in the dal-PLAQUE 2 (DP2) study to determine the correlation & clinical relevance of such imaging as related to coronary artery disease (CAD). Pts. who have had baseline angiography/IVUS, with or w/o baseline carotid ultrasound but NOT undergone follow-up angiography/IVUS as part of DP2 will have F/U angiogram/IVUS within 18-27 mos. of baseline imaging. Pts. who have had baseline carotid ultrasound but NOT undergone a F/U carotid ultrasound as part of DP2 will have follow-up carotid ultrasound within 18-27 mos. of baseline imaging. Main objectives is to compare: extent of atherosclerosis in coronary arteries with the extent of atherosclerosis in carotid arteries at a single point in time. Pts. who have successfully undergone baseline IVUS imaging, with or w/o baseline carotid ultrasound, in DP2 will be included. Pts., who successfully completed baseline angiography/IVUS in DP2, with or w/o baseline carotid ultrasound, will be scheduled for final F/U angiography/IVUS any time between 18-27 mos. after DP2 baseline imaging. Pts. who successfully completed baseline carotid ultrasound in DP2 will be scheduled for F/U carotid ultrasound any time between 18 -27 mos. after DP2 baseline imaging. Endpoints: death, death from coronary heart disease, resuscitated cardiac arrest, non-fatal MI, stroke, hospitalization for documented acute coronary syndrome, coronary revascularization procedure & carotid artery surgery or angioplasty. Pts. will have annual phone contact for 3 yrs. to check for the occurrence of cardiovascular & cerebrovascular clinical endpoints. Imaging parameters from this study will be combined with the imaging data from DP2 to compare coronary & carotid atherosclerosis extent at baseline & rate of progression up to 2 yrs.
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
This study is complementary to a multi-center, randomized, double-blind,parallel-group,
placebo-controlled, variable treatment duration study comparing the efficacy and safety of
BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both
immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the
setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the
central site.
Medtronic CoreValve® U.S. Expanded Use Study
The primary objective of the study is to evaluate the safety and effectiveness of the
Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme
Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a
composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic
severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled
in this study have a predicted operative mortality or serious, irreversible morbidity risk
of ≥50% at 30 days associated with surgical aortic valve replacement.
A Phase I/II Study of Immunotherapy with Humanized Anti-CD20
Antibody, IMMU-106 (hA20), in Adult Patients with Chronic Immune
Thrombocytopenic Purpura
Idiopathic thrombocytopenic purpura (ITP) is a condition in which the patient has very low platelet counts. It is believed that this is caused by the body's own immune system destroying the platelets. Initial treatment is with steroids and if this is not successful, removal of the spleen may be performed. Sometimes, the patient is refractory to all forms of therapy. CD20 is an antigen that is found on B cells. B cells are important in the immune system. Anti-CD20 is an antibody that targets the CD20 site on the B cell and can bind to this site inhibiting an important step in the proliferation of B cells thereby causing a depletion of these cells. The purpose of this study is to determine the optimal dose of the experimental agent IMMU-106 (an anti-CD-20 antibody) in patients with ITP. This is a Phase I/II study in which 3 different doses ( administered twice, 2 weeks apart, intravenously or by subcutaneous injection) will be evaluated for safety and to determine the optimal dose for later studies. An additional dosing schedule with hA20 administered by subcutaneous injection at a dose of 320 mg given once weekly for 4 consecutive weeks has been implemented. Initial subjects will be given infusions of the drug at the lowest of the three doses. If there is no significant toxicity, the next group of subjects will receive a higher dose and if there is again no significant toxicity, the third group will receive the highest dose. The subjects will be monitored for response to the drug, adverse effects, labs, physical exams, medical status and EKGs.
Effects of Oxytocin on Smoking
This study is examining the effects of a hormone called oxytocin on smoking. Oxytocin is a naturally occurring hormone in the brain and throughout the body In this study, oxytocin is experimental and is in the form of a nasal spray. We hope to learn if oxytocin nasal spray will help reduce the urge to smoke.
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Mycophenolate Mofetil and Rilonacept (Anti-interleukin-1) in Patients With Alcoholic Hepatitis
This is a prospective, randomized trial of two experimental treatments, prednisolone +
mycophenolate mofetil and prednisolone + rilonacept, in comparison with standard of care, in
patients with alcoholic hepatitis. Patients will start therapy with prednisolone. At Day 8
response to prednisolone will be determined using the Lille score. Patients with a Lille
score ≥ 0.45 will be randomized to standard of care (continue prednisolone, stop all therapy
and/or offer palliative care) or to have prednisolone continued and mycophenolate added for
the next three weeks. Patients with a Lille score <0.45 will be randomized to continue
prednisolone alone (standard of care) or to have rilonacept added to their treatment regimen
(experimental group) for the next three weeks. Patients will complete follow-up visits at
Week 12 and Week 24.
A pilot study of a mobile app to collect magnetic resonance imaging information in patients with multiple sclerosis
This pilot study examines the ability of a mobile application (app) to collect data from active tasks (such as questionnaires, 6Mapp™, COGapp™, VISapp™) and clinical magnetic resonance imaging information to analyze the extent to which genetics impact subjects with multiple sclerosis. Recruitment to the study will be done through different sources: patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.
Not yet recruiting | clinical magnetic resonance imaging | Not Multisite
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
BACKGROUND:
Evidence supporting a routine invasive practice paradigm for patients with stable ischemic
heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery
bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with
high-risk anatomic features. The relevance of these studies today is speculative because
contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and
lifestyle interventions—were used minimally if at all. Subsequent trials have compared
percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as
the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce
death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical
therapy in SIHD patients, found that among patients selected on the basis of coronary
anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI
or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or
death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine
cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be
required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had
ischemia level documented at baseline had only mild or moderate ischemia, leaving open the
question of the appropriate role of cath and revascularization among higher risk patients
with more severe ischemia. Observational data suggest that revascularization of patients
with moderate-to-severe ischemia is associated with a lower mortality than medical therapy
alone, but such data cannot establish a cause and effect relationship. In clinical practice
only about half such patients are referred for cath, indicating equipoise. Furthermore,
analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline
did not reveal a benefit from PCI. This issue cannot be resolved using available data
because all prior SIHD strategy trials enrolled patients after cath, introducing undefined
selection biases (e.g., highest risk patients not enrolled) and making translation of study
results problematic for clinicians managing patients who have not yet had cath.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been
performed before COURAGE and BARI 2D results were available) is needed to inform optimal
management for such patients.
DESIGN NARRATIVE:
The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0
was approved in January 2014.
PARTICIPATING COUNTRIES:
North America
- Canada
- Mexico
- USA (~150 sites)
South America
- Argentina
- Brazil
- Chile
- Peru
Asia
- China
- India
- Japan
- Singapore
- Taiwan
- Thailand
- Russian Federation
Pacifica
- Australia
- New Zealand
Europe
- Austria
- Belgium
- Denmark
- France
- Germany
- Hungary
- Italy
- Lithuania
- Macedonia
- Netherlands
- Poland
- Portugal
- Romania
- Serbia
- Spain
- Sweden
- UK
Middle East
- Israel
- Saudi Arabia
- Turkey
Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema
The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to
decrease volume in targeted regions of the lung. It is indicated for the treatment of
patients with severe emphysema. The EBV are placed in the diseased region of the lung using
bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on
the end. As the diseased region of the lung shrinks in size, healthier regions may expand
and function more efficiently, resulting in improved breathing.
The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random
to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the
Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control'
group will receive optimal medical therapy alone. For every three participants in the study,
two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that after placement of the EBV, lung function will be improved as
compared to standard medical therapy alone.
Project FIRE: Understanding the health effects of wildfires
Wildfire seasons are increasing in length and frequency, putting more people at risk to the effects of wildfire smoke. Project FIRE (Fire Impact REsearch) aims to investigate the acute effects of wildfires on human health. To this end, we have developed a smartphone application (app) that will be made freely available to our study participants. We will use this app to collect data on smoke exposure and health symptoms before, during, and after a wildfire. The findings from this study will help us understand how wildfires affect people’s health so that ultimately, we can better prepare for future wildfires and minimize health risks to communities.
Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Skin diseases account for 30% of all physician office visits. In the United States, access to
dermatologists remains a significant challenge for those in underserved or rural communities.
To increase access to specialists and improve patient outcomes, we will evaluate a team-based
connected health (TCH) model that enables structured asynchronous online interactions among
patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable
effective management of chronic skin diseases via high-quality and efficient online care
between providers and patients. TCH purports to bring direct and expedient specialist care to
patients and PCPs in a location-independent and asynchronous manner.
Specifically, TCH offers several ways that patients and providers can communicate online
asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and
(3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access
dermatologists online asynchronously for consultations or to request a dermatologist to
assume care of patient's skin disease. With patient-dermatologist interactions, patients can
upload clinical images and history online and obtain asynchronous evaluation and
recommendations from dermatologists directly. Finally, PCPs have the option of managing their
patients' skin diseases online. Importantly, TCH applies efficient workflow that maximally
supports providers and fosters multi-directional, informed communication among patients,
PCPs, and dermatologists.
To evaluate the impact of TCH, we use atopic dermatitis (AD) as a disease model. AD is a
common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD
is characterized by intense itching and red, scaly patches. It incurs significant morbidities
and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences,
PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects
of AD.
The primary goal of the proposed research is to test whether the online TCH model results in
equivalent improvements in disease severity and quality of life, provides better access to
specialist care, and is cost- saving as compared to usual in-person care in pediatric and
adult patients with AD. Specifically, we will conduct a pragmatic, cluster-randomized
controlled equivalency trial and use validated measures to compare AD disease severity,
health-related quality of life, and access to care between TCH and in-person care. We will
also compare costs of the two healthcare delivery models from a societal perspective by
conducting cost- minimization and sensitivity analyses.
This proposal evaluates a significant innovation in specialty-care delivery that will likely
result in improved patient outcomes, greater access to specialists, and cost savings. The
study findings will be highly impactful and have immense dissemination potential to the
management of many other chronic diseases.
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD
System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal
study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic
treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy
will be evaluated.
Not recruiting | High Blood Pressure / Hypertension | Site Unknown
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
New study helps predict the risk of falling in people post-stroke
Taking precautions to prevent falling after stroke is very important. Falls can cause broken bones, increased disability, and even death. The purpose of this study is to find out whether we can train stroke patients to walk in a way that lowers their risk of falling. The study will look at the advantages and disadvantages of restoring symmetry in the walking patterns of stroke survivors. The research team is looking for stroke patients who are interested in joining the study.
A Randomized Phase II Trial of Cytotoxic Chemotherapy With or Without Epigenetic Priming in Patients With Advanced Non-small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. Percentage of patients progression-free at 6 months from time of randomization.
SECONDARY OBJECTIVES:
I. Progression-free survival (PFS). II. Overall Survival (OS).
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive azacitidine subcutaneously (SC) on days 1-6 and 8-10 and entinostat
orally (PO) on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients with stable or progressive disease
receive chemotherapy of the treating oncologist's choice comprising irinotecan hydrochloride
intravenously (IV) on day 1, docetaxel IV on day 1, pemetrexed disodium IV on day 1, or
gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.
ARM B: Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10.
Treatment repeats every 28 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of
the treating oncologist's choice as in Arm A.
ARM C: Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
After completion of treatment, patients are followed up every 3-6 months for 24 months and
then yearly thereafter.
How the diet of breastfeeding Latina moms affects the health of their babies
This study looks at the effects of sugar in Hispanic/Latina moms and their babies. Previous studies have found that eating and drinking too much sugar can cause weight gain and health problems that affect the liver, kidneys, and heart. Feeding sugar to children can cause health problems that affect their growth and development. Hispanic/Latina moms and their babies are more at risk for these health problems than other groups. <strong>We want to find out whether an education program to reduce sugar improves the health of Hispanic/Latina moms and their babies. Come join the MAMITA Study if you are a pregnant or have a newborn.</strong>
Phase I/II Trial of Cediranib Alone or Cediranib and Lenalidomide in Iodine 131-Refractory Differentiated Thyroid Cancer
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of cediranib (cediranib maleate) plus
lenalidomide. (Phase I) II. Determine the progression-free survival rates of single agent
cediranib in patients with iodine refractory, unresectable differentiated thyroid cancer
(DTC) who have evidence of disease progression within 12 months of study enrollment. (Phase
II) III. Determine the progression-free survival rates of cediranib in combination with
lenalidomide in patients with iodine refractory, unresectable DTC who have evidence of
disease progression within 12 months of study enrollment. (Phase II) IV. Compare the
progression-free survival curves of single agent cediranib to combination therapy with
cediranib with lenalidomide. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the response rate of cediranib in combination with lenalidomide in patients
with iodine refractory, unresectable DTC who have evidence of disease progression within 12
months of study enrollment. (Phase I) II. Determine the toxicity, duration of response,
progression free survival, and overall survival in patients with DTC treated with cediranib
plus lenalidomide. (Phase I) III. Determine response rates and duration of response, early
tumor size changes, the toxicity, and overall survival in patients with DTC treated with
cediranib or cediranib plus lenalidomide. (Phase II) IV. Determine whether the presence of
v-raf murine sarcoma viral oncogene homolog B1 (B-RAF) or V-Ki-ras2 Kirsten rat sarcoma
(K-RAS) mutations in patients with DTC predict response to cediranib or cediranib plus
lenalidomide. (Phase II)
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Phase I: Patients receive cediranib maleate orally (PO) once daily (QD) on days 1-28 and
lenalidomide PO QD on days 1-21 or 1-28. Courses repeat every 4 weeks in the absence of
disease progression or unacceptable toxicity.
Phase II: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 4 weeks
in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive cediranib maleate PO and lenalidomide PO as in Phase I.
After completion of study treatment, patients are followed up periodically.
Not recruiting | Head and Neck Cancers | Multisite
Phase I/II Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of high dose interleukin 2 (aldesleukin) in
combination with entinostat in patients with metastatic renal cell carcinoma (RCC). (Phase
I) II. To monitor toxicity and estimate the efficacy of high dose aldesleukin combined with
entinostat in patients with metastatic RCC. (Phase II)
SECONDARY OBJECTIVES:
I. To compare the time-to-tumor progression, progression-free survival and overall survival
of patients with metastatic RCC treated with high dose aldesleukin combined with entinostat
to the historical data of patients treated with high dose aldesleukin alone. (Phase II) II.
To assess the toxicity of high dose aldesleukin combined with entinostat. (Phase II) III. To
evaluate entinostat pharmacodynamics (PD) in blood and tumor samples. (Phase II) IV. To
measure the association between baseline laboratory parameters (e.g. cluster of
differentiation [CD]4+, CD8+, CD4+/forkhead box P3 [Foxp3]), tumor blood metabolism, and a
variety of response variables (e.g. toxicity, response and survival). (Phase II) V. To
explore the relationship between entinostat exposure with PD endpoints (e.g. toxicity and
histone acetylation in peripheral blood mononuclear cells or peripheral blood mononuclear
cells [PBMNCs] and changes in T cell subset population). (Phase II) VI. To evaluate the
modulation of tumor metabolism by fluorodeoxyglucose (FDG, fludeoxyglucose F 18) positron
emission tomography (PET)/computed tomography (CT) scan. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of entinostat followed by a phase II
study.
Patients receive entinostat orally (PO) every 2 weeks beginning on day -14 and high-dose
aldesleukin intravenously (IV) every 8 hours on days 1-5 and 15-19. Courses repeat every 84
days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients with evidence of tumor shrinkage may receive up to 3 courses of high-dose
aldesleukin therapy. Patients with stable disease by Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.0 criteria, but without evidence of tumor shrinkage after two
courses will receive only entinostat until disease progression is documented.
After completion of study treatment, patients are followed up at 30 days and then every 3
months thereafter.
A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction
PRIMARY OBJECTIVES:
I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in
patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)^V600X mutations and
renal or hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To assess for tumor response and various times to clinical event. II. To provide dosing
recommendations for dabrafenib in patients with varying degrees of hepatic and renal
dysfunction for possible inclusion in the label.
TERTIARY OBJECTIVES:
I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active
metabolites.
OUTLINE: This is a dose-escalation study.
Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily [QD] on
day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
3C-14-5: A Double-blind, Randomized, Placebo Controlled Phase III Study of Nintedanib plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with Colorectal Cancer Refractory to Standard Therapies
Colorectal cancer is the second leading cause of cancer-related deaths in Western countries. About half of patients eventually develop metastatic disease. Virtually all patients with advanced metastatic colorectal cancer will sooner or later become refractory to standard treatment, and will eventually succumb to their disease.
Despite clinical advances reported in the treatment of metastatic colorectal cancer by using combination of chemotherapy and targeted therapies, there is need for more effective agents for patients with refractory metastatic colorectal cancer.
VEGFR-2 is considered the crucial molecule involved in formation as well as the maintenance of tumor. Nintedanib is a potent small molecule inhibiting VEGFR receptor family, leading to anti-tumor effects.
The purpose/objective of this study is to evaluate the efficacy and safety of nintedanib in
patients with metastatic colorectal cancer after failure of previous treatment with standard chemotherapy and biological agents.
Study participants will be randomly assigned in a 1:1 ratio to receive either nintedanib + best supportive care (Arm A) or matching placebo + best supportive care (Arm B). Best supportive care that is considered standard treatment option after failure of approved available anti-cancer treatments.
Participants will receive study treatment until unequivocal progression or undue toxicity; no other anti-cancer treatment will be allowed until study drug is discontinued.
Evaluation of tumor response will be assessed by imaging every 6 weeks. The investigators decision about continuation of study treatment will be based on assessment of tumor response and progression.
Not recruiting | Colon / Rectal Cancer | Multisite
Norris ORIEN Total Cancer Care Protocol: A Lifetime Partnership With Patients
PRIMARY OBJECTIVES:
I. To establish a longitudinal study of clinical and related data from patients with or at
risk for cancer.
II. To establish a large biospecimen repository that is linked to clinical and related data.
III. To follow patients through their lifetime though passive or active follow-up.
IV. To use clinical data, tissues, other biological samples and derived molecular data in the
Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future
studies.
OUTLINE:
Patients undergo collection of blood during a regular care visit or not up to 4 times a year.
Extra tissue is collected after removal during standard of care surgery and patients may
undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies.
During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone
marrow for research will not be collected more than 4 times per year. Patients may undergo
additional collection of other biological samples such as saliva, sputum, urine, feces, hair,
and surface skin swabs for analysis. Patients also receive surveys or questionnaires to
collect demographics, medical, family, and nutritional history, cancer predisposing risk
factors, quality of life data, and quality of care data.
After completion of study, patients are followed up periodically.
4P-10-8: PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Nave Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
This is a research study for individuals who have been diagnosed with cancer of the prostate that is getting worse despite receiving hormone treatment. This study will use MDV3100, an experimental drug, that has not been approved for sale to the public by the United States Food and Drug Administration (US FDA) or other government and health regulatory agencies. The purpose of this study is to determine if MDV3100 will help the study participants live longer, if MDV3100 can delay the progression of cancer by increasing the amount of time before the cancer progresses, and to determine the safety of the study drug.MDV3100 is an experimental drug known as an androgen-receptor antagonist (it blocks the activity of the male sex hormones). It directly affects a key mechanism in the body that leads to prostate cancer cell death. Prostate cancers are initially dependent on the male hormone testosterone for growth. Hormonal therapies that lower testosterone or block the ability of testosterone to act at the level of the prostate cancer are currently among the most effective treatments for prostate cancers that have spread to other body organs (metastasized). The effectiveness of hormonal treatments, however, is not permanent, and over time many prostate cancers progress in spite of these treatments. This study is a multicenter, phase 3 double-blind placebo-controlled study. This study is a blinded study, which means that neither the study participants nor the study doctor will know if they are taking MDV3100 or placebo. The experimental drug, MDV3100 is provided as a 40 mg soft gelatin capsule and is indicated at a dose of 160 mg/day administered once daily. The study drug may be taken with or without food.The study drug will be continued as long as the study participant is tolerating the study drug and continues androgen deprivation treatment until confirmed disease progression through imaging.The safety of the study drug will be determined by the frequency of serious adverse events, frequency and severity of adverse events, frequency of study drug discontinuation due to adverse events as well as the frequency of new clinically significant changes in physical examination findings, vital signs, laboratory values and ECGs.The efficacy analyses will be conducted using the intent-to-treat population defined as all randomized participants.The study will be conducted at 225 locations worldwide. About 1,680 people will participate in this study, 10 will be from USC.
A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
PRIMARY OBJECTIVES:
I. To evaluate the effect of a brief educational program on colorectal cancer knowledge
acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment
Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing
visual/written educational material with and without mindfulness training to the standard of
care.
II. To determine the priming effect of a brief mindfulness training on retaining knowledge
of colorectal cancer education.
III. To determine the joint effect of colorectal cancer education delivered to both the
patient and a caregiver on the overall colorectal cancer knowledge.
SECONDARY OBJECTIVES:
I. To examine the relative changes in psychobiological variables (stress, anxiety,
depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in
the 3 arms of the clinical trials.
II. To measure changes in salivary cortisol levels as an indicator of acute stress
reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60
min) during active chemotherapy (T1).
III. To determine the moderating effect of baseline peripheral levels of inflammation
(interleukin-1 [IL-1], IL-6, c-reactive protein [CRP] and tumor necrosis factor alpha
[TNFa]) on the trajectory of salivary cortisol reactivity.
OUTLINE: Patients and caregivers are randomized to 1 of 3 groups.
GROUP I: Patients and caregivers receive standard of care.
GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational
video brochure.
GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational
video brochure and watch a 20-minute interactive mindfulness exercise video.
Not recruiting | Colon / Rectal Cancer | Not Multisite
0C-14-4 A Phase I, multi-center, non-randomized, open label, parallel-group study evaluating the pharmacokinetics and safety of regorafenib (BAY 73-4506) in cancer subjects with severe renal impairment compared to a control group
Regorafenib is a targeted agent that has been shown to have anti-cancer activity and has been approved for use in previously treated patients with advanced colorectal cancer and gastrointestinal stromal tumors. Regorafenib is processed in the body or metabolized mostly through the liver, but the FDA recommends that a pharmacokinetic (PK) study be conducted in patients with damaged kidney function since damaged kidney function can alter the PK of the drug. PK studies look at what the body does to the drug in terms of how it is absorbed, distributed, metabolized, and excreted. The PK of regorafenib has been studied in patients with mild kidney damage, but not in patients with severe kidney damage or end-stage kidney disease. This open-label, Phase 1 study is being done with a primary objective to evaluate the impact of severe kidney damage on the PK of regorafenib in subjects with advanced solid tumors as compared to those with normal kidney function. There will be 2 groups of kidney function evaluated (Group 1 Control: normal/mild damage, Group 2: severe damage).
Once patients have signed consent and are deemed eligible, they will be assigned to one of two groups according to their kidney function status. Each group will have a minimum of 12 subjects. The study will be done in 2 stages. In the first stage, all subjects will receive one dose of regorafenib and have PK bloods collected for up to 4 days. They will enter into the second phase if they are willing and the study doctor thinks that they will benefit. They will continue to have study visits and receive study drug until they have side effect(s) or a condition which necessitates their removal from the study, they are lost to follow up, their disease progresses, they become pregnant, the protocol is not followed, they withdraw consent, their study doctor thinks that being on the study is no longer in their best interest, or the sponsor stops the study.
The PK and safety data will be summarized and analyzed by kidney function group. Summary statistics will be presented by treatment group. Medical history findings will be summarized for all subjects. The primary pharmacokinetic analysis will be based on classification of renal function using the C-G formula. The following statistics will be calculated for each of the PK sampling points and characteristics: arithmetic mean, standard deviation and coefficient of variation (CV), geometric mean, geometric standard deviation (re-transformed standard deviation of the logarithms) and CV, minimum, median, maximum value and the number of measurements. Individual and geometric mean concentration vs. time curves of all analytes will be plotted by treatment using both linear and semilogarithmic scale. To compare the two kidney function groups, AUC(0-24)md estimated with nominal dosing will be analyzed assuming log-normally distributed data.
A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
OBJECTIVES:
Primary
- To determine whether the addition of short-term androgen deprivation (STAD) to prostate
bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a
prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical
failure, and absence of death from any cause) for 5 years, over that of PBRT alone in
men treated with salvage radiotherapy after radical prostatectomy.
- To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves
FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy
after radical prostatectomy.
Secondary
- To compare the rates of a PSA ≥ 0.4 ng/mL and rising at 5 years after randomization
(secondary biochemical failure endpoint), the development of hormone-refractory disease
(3 rises in PSA during treatment with salvage androgen-deprivation therapy), distant
metastasis, cause-specific mortality, and overall mortality.
- To compare acute and late morbidity based on Common Toxicity Criteria for Adverse
Effects (CTCAE), v. 3.0.
- To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related
genes in archival diagnostic tissue to better define the risk of FFP, distant failure,
cause-specific mortality, and overall mortality after salvage radiotherapy for prostate
cancer, independently of conventional clinical parameters now used.
- To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms)
patterns and urine-based genomic patterns before and at different times after treatment
to better define the risk of FFP, distant failure, cause-specific mortality, and
overall mortality after salvage radiotherapy for prostate cancer, independently of
conventional clinical parameters now used.
- To assess the degree, duration, and significant differences of disease-specific
health-related quality of life (HRQOL) decrements among treatment arms.
- To assess whether mood is improved and depression is decreased with the more aggressive
therapy if it improves FFP.
- To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells
for future translational research analyses.
Tertiary
- To assess whether an incremental gain in FFP and survival with more aggressive therapy
outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self
care, usual activities, pain/discomfort, and anxiety/depression).
- To evaluate the cost-utility of the treatment arm demonstrating the most significant
benefit (in terms of the primary outcome) in comparison with other widely accepted
cancer and non-cancer therapies.
- To assess associations between serum levels of beta-amyloid and measures of cognition
and mood and depression.
- An exploratory aim is to assess the relationship(s) between the American Urological
Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading
system.
OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no),
prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs >
1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients
are randomized to 1 of 3 treatment arms.
- Arm I (prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5
days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions).
- Arm II (PBRT and short-term androgen-deprivation [STAD]): Beginning 2 months before the
start of PBRT, patients undergo STAD, using a combination of antiandrogen and
luteinizing hormone-releasing hormone (LHRH) agonist therapy, for a total of 4-6
months. Patients receive antiandrogen therapy comprising either oral flutamide 3 times
daily or oral bicalutamide once daily for at least 4 months (started within 1-14 days
prior to the LHRH agonist and ending the last day of radiotherapy ± 14 days). Patients
receive LHRH agonist injection beginning concurrently with or 2 weeks after the start
of antiandrogen therapy. LHRH agonist injection consists of analogs approved by the FDA
(or by Health Canada for Canadian institutions) (e.g., leuprolide, goserelin,
buserelin, or triptorelin) and may be given in any possible combination (may be given
as a single 4-month injection and one to two 1-month injection[s], two 3-month
injections, or a 6-month injection), such that the total LHRH agonist treatment time is
4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in
arm I.
- Arm III (Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months
before the start of radiotherapy, patients receive STAD therapy as in arm II.
Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once
daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions)
followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14
fractions).
Patients complete the American Urological Association Symptom Index (AUA SI) questionnaire
prior to protocol treatment, at week 6 of radiotherapy, and then periodically after
completion of study therapy.
After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for 4 years, and then annually thereafter.
S0702, "A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment.
This study is about Zoledronic acid that falls under a category of drugs called bisphosphonates. Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ). Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone. There is concern about the association of ONJ with bisphosphonate therapy.The primary objective of this study is to prospectively assess, how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment.This is not a treatment study. This study involves collecting information about the treatment with zoledronic acid and collecting information about participants general health and medical history, oral health and dental history and pain assessment through questionnaires.Participants go through some exams, tests or procedures that are part of regular cancer care, like Blood work, Dental exam, Oral x-rays, Medical and dental history, Physical exam.Every six months for up to three years, participants will be asked to provideInformation regarding current treatment for metastatic bone diseaseInformation about any health problems they are havingInformation about their medical history, treatments and physical examInformation regarding their oral health, dental history and exams and pain assessmentIf at any time participants are diagnosed with osteonecrosis of the jaw (ONJ)Every three months for up to three years, they will be asked to provideInformation regarding current treatment for ONJInformation about any health problems they are having with the zoledronic acidInformation regarding oral complications and recent dental proceduresUpdated information on their medical history, physical exam, and treatmentSubmission of dental x-rays and scansThe primary endpoint is the diagnosis of confirmed ONJ. For statistical consideration the goal of this study is to estimate the cumulative incidence rate of confirmed ONJ associated with zoledronic acid at 3 years in patients with bone metastases.About 3,500 people will take part in this study nationally; 200 research participants from USC will take part in this study.
Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
PRIMARY OBJECTIVES:
I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate
cancer collected before and during treatment of the disease with abiraterone acetate
(Zytiga) or enzalutamide (Xtandi).
II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma
collected from 75 patients with progressing advanced metastatic prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.
GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain
reaction (PCR) and next generation sequencing (NSG).
GROUP II: Patients undergo collection of blood samples before and following systemic therapy
for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and
NSG.
A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
This Phase II study will enroll patients into three groups. Group 1 are patients who have
never been treated with bevacizumab. These patients will be randomly assigned to receive
either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for
Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to
bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or
within 2 months of discontinuing bevacizumab). These patients will all receive
rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease
progression or intolerance and all patients will be followed for survival. Patients may be
treated with other therapies that are not part of the study after discontinuing treatment
with the study vaccine.
Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease.
SECONDARY OBJECTIVES:
I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 criteria) of the GE regimen in these patients.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 36 months.
A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic
sampling of the neck lymph nodes in patients with head and neck cancer planning to
undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult
metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local
sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary
tumors, or intensity of FDG uptake) that can lead to identification of subsets of
patients that could potentially forego neck dissection or that can provide preliminary
data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer
vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body
PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose
management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to
metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct
assessment of their prediction of recurrence, disease-free survival, and overall
survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels
that clinicians intend to dissect beyond the initial surgery plan) based on
local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy
of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites
(defined by anatomic location).
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients
undergo unilateral or bilateral neck dissection.
Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months
after surgery.
Patients undergo blood and tissue sample collection periodically for biomarker analysis.
Patients are followed up periodically for up to 2 years after surgery.
Not recruiting | Head and Neck Cancers | Multisite
Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide,
abiraterone and prednisone. Treatment will continue until disease progression or
unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years
post study treatment. The primary and secondary objectives are described below.
1. Primary Objective:
To compare the overall survival of patients with progressive metastatic
castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or
enzalutamide with abiraterone and prednisone
2. Secondary Objectives:
- To assess the grade 3 or higher toxicity profile and compare safety by treatment
arm.
- To assess and compare post-treatment prostate-specific antigen (PSA) declines by
treatment arm.
- To compare radiographic progression free survival defined by Prostate Cancer
Working Group 2 (PCWG2), and objective response rate, by treatment arm.
- To test for radiographic progression free survival (rPFS) treatment interaction in
predicting overall survival.
- To assess pre- and post-treatment measures of tumor burden and bone activity using
sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT)
and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate
these measures with overall survival.
- To develop and validate prognostic and predictive models of overall survival that
include baseline clinical and molecular markers.
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease
PRIMARY OBJECTIVES:
I. To evaluate and compare progression free survival (PFS) of two different doses of
carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or
refractory disease.
SECONDARY OBJECTIVES:
I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates
(RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high
dose carfilzomib.
III. To evaluate the safety of this combination for this patient population. IV. To evaluate
overall survival (OS).
TERTIARY OBJECTIVES:
I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow
relapse sites.
II. To explore the role of positron emission tomography (PET) scanning in assessing disease
burden and as a tool to assess treatment response.
III. To explore changes in left ventricular ejection fraction (LVEF) in patients with
relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose
carfilzomib plus dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over
2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II.
ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on
days 1, 2, 8, 9, 15, and 16.
Note that for the first course of treatment on both arms carfilzomib is given at a reduced
rate to assess toxicity.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years
from initial registration.
3C-14-1: A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer
This is a Phase 2 open-label, multi-center, 2-stage Simon design stage trial of nivolumab (BMS-936558) monotherapy (mStage) or in combination with ipilimumab (cStage) to estimate the response rate in Metastatic Microsatellite MSI-High colon cancer. Ipilimumab is a fully humanized IgG1 monoclonal antibody binding to the anti-cytotoxic T-cell lymphoma-4 antigen (CTLA-4). Ipilimumab is an approved therapy for metastatic melanoma.Nivolumab (BMS-936558; anti-PD-1 mAb) is a fully human monoclonal immunoglobulin (Ig) G4 antibody that binds to the programmed death-1 (PD-1), a negative regulatory molecule expressed by immune cells.Primary Objective of the study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H colon cancer.The study will also contain a safety cohort of subjects with non-MSI-H colon cancer to assess the safety and tolerability of nivolumab in combination with ipilimumab in subjects with non-MSI-H colon cancerBoth Arms N and N+I will follow a two-stage design to test whether nivolumab monotherapy or nivolumab combined with ipilimumab yields an objective response rate (ORR) that is of clinical interest in MSI-H metastatic colorectal cancer mCRC. On treatment stages that meet an ORR threshold will proceed from Stage 1 to Stage 2 (same for both m and cStage). The primary endpoint of this study ORR which is based on tumor assessments at baseline and then at 6 weeks from first dose and continue every 6 weeks for the first 24 weeks and every 12 weeks thereafter until disease progressionThe study will enroll 96 patients out of which 15 will be enrolled at USC
Not recruiting | Colon / Rectal Cancer | Multisite
16M-14-1: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma
Multiple myeloma is a type of blood cancer caused by the transformation and uncontrolled multiplication of plasma cells (a type pf blood cell). It is the second most common hematological malignancy and is invariably fatal. Myeloma cells expand in the bone marrow causing skeletal destruction, high calcium levels, kidney failure and anemia.
The study population will consist of multiple myeloma patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy.
The study drug, oprozomib works by preventing the breakdown of certain proteins in cells, causing the cells to die. Studies with oprozomib have been able to demonstrate the treatment potential for blocking proteasomes (protein complexes) in multiple myeloma. These proteasomes main function is to degrade unneeded or damaged proteins.
The primary objective of Phase 2 is to estimate the overall response rate.
This study is an open-label, Phase 1b/2, multicenter study in which participants will receive oprozomib administered orally, once daily, in combination with dexamethasone as follows:
Days 1, 2, 8, and 9 of a 14-day cycle;
Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
USC will only participate in Phase 2. The Phase 2 portion of this study will be initiated at the sponsors discretion using the recommended dose determined from 1 or both dosing schedules. The total study duration is expected to be approximately 26 months.
0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Not recruiting | Any Cancer Condition or Solid Tumor | Multisite
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.
The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3,
VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models.
The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can
provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or
FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in
patients not known to have FGF abnormalities.
Based on these results, is study is designed to explore the safety and anti-tumor activity
of daily lucitanib in breast cancer patients with and without alterations of the FGF
pathway.
A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
Lung cancer remains the most common cancer worldwide with non-small cell lung cancer
accounting for 85% of cases. Cytotoxic chemotherapy has been the mainstay of patients with
NSCLC; however, survival rates remain low and toxicity is significant. Molecularly targeted
therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have
mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the
gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs
eventually progress, and in approximately 50% of cases, progression is due to development of
an additional mutation called T790M. There are currently no approved therapies for patients
who progress on TKIs. Rociletinib may provide an effective therapy for a patient population
with few alternative treatment options. Nonclinical data demonstrate that rociletinib
inhibits T790M. It is anticipated that rociletinib may promote cell death in tumor cells
with the T790M mutation, thus providing possible therapeutic benefit in patients who have
developed T790M-mediated resistance to first generation TKIs.
This is a two-part, open-label study of oral rociletinib administered daily in previously
treated NSCLC patients who have documented evidence of an activating mutation in the EGFR
gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or
afatinib.
This study will include 2 parts:
Phase 1 (completed enrolment): Dose-escalation Period with 21-day cycles; optional Treatment
Extension Period starting on Day 22
Phase 2 (currently enrolling): Evaluation of activity and safety in patients with the T790M
EGFR mutation who have:
Cohort A - Progressed on EGFR directed therapy (irrespective of the number and order of
previous lines of NSCLC therapy) or Cohort B - Progression on the first single agent EGFR
directed therapy received and also had no more than one previous line of chemotherapy
Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma or Multiple Myeloma
This is a Phase I, open-label, multi-center dose-escalation trial evaluating the safety and
tolerability of CUDC-907 as a single agent administered orally, once daily, to patients with
relapsed or refractory lymphoma or multiple myeloma. The following dosing schedules may be
examined, all consisting of 21-day cycles and including:
(i) continuous once daily (QD), (ii) twice weekly on Days 1, 4, 8, 11, 15, 18 (BIW) (iii)
thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17, 19 (TIW) (iv) four days on/three days off
on Days 1-4, 8-11, and 15-18 (4/3), and (v) five days on/two days off on Days 1-5, 8-12, and
15-19 (5/2)
Sequential dose escalation cohorts of oral CUDC-907 are planned. Subject enrollment and dose
escalation will proceed according to a standard 3+3 design. In the absence of DLT, each
subject will be treated for a minimum of 21 days, and may continue to receive additional
treatment until disease progression has been documented or other treatment discontinuation
criteria have been met.
MTD or BED expansion cohorts of up to 36 evaluable (e.g., up to 12 subjects in each of 2 or
3 specific tumor types or subtype) to better define the safety, tolerability and preliminary
antitumor and pharmacodynamic activity of the study treatment, as well as suitability as an
RP2D and schedule.
Safety and tolerability will be assessed by the incidence and severity of adverse events as
determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE v4.03). A Safety Review Committee (SRC) comprised of the Medical Monitor, Principal
Investigators, and Sponsor representatives, will be convened to review safety information
and to decide upon dose escalation and further subject enrollment.
The antitumor activity of study treatment will be assessed according to standard response
criteria as appropriate for each individual subject's tumor type (e.g., Revised Response
Criteria for Malignant Lymphoma and the International Uniform Response Criteria for Multiple
Myeloma).
Exploratory biological markers of activity will be assessed in peripheral blood mononuclear
cells (PBMC), plasma and tissue specimens (skin, tumor and bone marrow samples, where
available).
A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Phase I Design
A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will
likely be necessary to determine the MTD of temsirolimus in combination with neratinib.
There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg
administered intravenously weekly (dose level 1). Three patients will initially be enrolled
in each cohort. The Phase I portion is closed to enrollment.
Phase II Design
The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and
triple negative breast cancer—each of which has a Simon two-stage design to determine the
efficacy of temsirolimus when administered in combination with neratinib. Both pathologic
subtypes of patients will be studied separately though accrual will be simultaneous.
Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start
of therapy. As of 2/10/12, the Triple-negative cohort is closed to accrual. The HER2-
amplified cohort will continue to enroll as planned up to a total of 34 patients.
0C-10-4: A Phase Ia/Ib Clinical Trial of PRI-724 in Patients with Advanced Solid Tumors
Despite recent progresses in directed chemotherapy, the modern anti-cancer armamentarium only eradicates the majority of drug-sensitive and differentiated tumor cells. Unfortunately, to date no effective therapeutic solution has been developed to treat cancer stem cells. Based on pre-clinical research utilizing CREB-binding proteins/ beta-catenin antagonists, it is hypothesized that such antagonists can target CSCs and thereby offer a novel anti-tumor therapeutic approach.This is a Phase Ia/Ib clinical trial of PRI-724 in patients with advanced solid tumors. It has 2 arms:Phase Ia Accelerated Phase/Dose Escalation and Phase Ib Dose Expansion: PRI-724 MTDThe primary objective of the study is to determine the maximally tolerated dose (MTD) of PRI-724 when administered as a continuous 7-day intravenous infusion to patients with solid tumors. This has been completed in Phase 1a of the study. The Phase 1b will determine the MTD of PRI-274 when combined with mFOLFOX6 in patients with colorectal carcinoma.The secondary objectives are to describe the side effects experienced in both parts of the study, determine the pharmacokinetic profile of PRI-724 and C-82, assess anti-tumor activity, assess the genetic expression of survivin and the effect PRI-724 has on survivin, and assess the affect of C-82 on hair follicle neogenesis and collagen expression. The study also has an exploratory objective to obtain matrix metalloproteinase-7 (MMP7) levels in serum via enzyme-linked immunosorbent assay (ELISA) testing.The starting dose and dose escalation scheme was selected to provide an adequate safety margin based on Good Laboratory Practices (GLP) 28-day continuous iv infusion nonclinical studies. The study consists of accelerated Phase Ia and dose escalation at standard 3+3 phase. Each cycle is defined as 7-day continuous intravenous (iv) infusion followed by a 7-day rest period. At the Maximally Tolerated Dose (MTD), Phase Ib will commence where 18 patients with advanced colorectal cancer who have progressed or whose tumors are no longer responsive to standard therapies will be enrolled.The exact number of patients enrolled will depend on the toxicity observed in each dose escalation cohort and the number of cohorts required to reach MTD.The mRNA level of surviving will be measured in both Phase Ia and Ib. If mRNA level of surviving at day 8 of PRI-724 treatment is decreased 30% or more compared to the level prior to PRI-724 treatment, it suggests that PRI-724 inhibits surviving. In addition to this, assessment will be made of clinical endpoints including tumor response by RECIST and progression-free survival by tumor specimen and circulating tumor cells in every cohort.A typical electronic data capture (EDC) system will be used for data collection.Statistical analysis will be carried out by USC Norris Comprehensive Cancer Center Biostatistics core using SAS Version 9.0 or later.
Lean on me: Research Study for Couples Trying to Stop Smoking
<p>
If you are trying to quit smoking cigarettes, it may be more difficult if your significant other also smokes. Researchers at USC would like to understand whether having a romantic partner who also smokes affects a smoker's attempts to quit. What we learn will help us to develop more effective programs for those who want to quit.</p><p>Relationships are common reasons why people start or continue to smoke. Maybe you grew up around smokers and it seemed natural for you to smoke, too. Maybe your partner smokes and it’s a way that you spend time together. The important people in your life can also be a key to your success in quitting. You might even be surprised by how much help they can be.
</p><p>
If you participate in the study, we will ask you to visit our USC Health Science Campus lab, complete some questionnaires and interviews about your smoking history and your mood, and complete daily mobile surveys for 4 weeks using your phone. One or both individuals in a relationship can participate, and at least one person has to be a smoker.
</p>
A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a randomized (individuals assigned to study treatment by chance), open-label
(identity of assigned study drug will be known), active-controlled study in adult female
patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal,
or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria
defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL
combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin)
monotherapy group (Arm B). During the treatment phase, patients will receive study drug
infusions according to 21-day cycles in Arm A and 28-day cycles in Arm B. Treatment will
continue until the occurrence of disease progression or unacceptable treatment toxicity, or
until 2 cycles beyond a confirmed complete response is documented. Up to 2 additional cycles
of study drug are allowed after complete response, at the discretion of the principal
investigator. Efficacy assessments will be evaluated using Response Evaluation Criteria in
Solid Tumors. Disease assessments, including assessments for patients who discontinue
treatment for reasons other than disease progression, will be performed until disease
progression, the start of subsequent anticancer therapy, withdrawal of consent, or the
clinical cutoff date. Collection of survival status will continue until at least 514 deaths
have been observed. Serial pharmacokinetic (PK) samples will be collected in a subset of
patients who voluntarily consent to the PK portion of the study. Safety will be monitored
throughout the study. An interim analysis of overall survival (OS) will be performed after
approximately 308 participants have died. The final analysis of OS will occur when
approximately 514 deaths have been observed.
An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guérin (BCG).
Bladder cancer is the 6th most common cancer in the United States, affecting more men than
women. The usual first treatment for NMIBC (Ta, T1, and CIS) is transurethral resection of
the bladder tumors followed by intravesical immunotherapy, most commonly with bacillus
Calmette-Guérin (BCG).
Because of the high risk for development of muscle invasive disease, cystectomy is
recommended for CIS and high-grade Ta and T1 patients who experience disease recurrence
following intravesical therapy. For patients unable or unwilling to undergo cystectomy,
treatment options are limited.
Vicinium contains the active pharmaceutical ingredient VB4-845, which is a recombinant fusion
protein produced in Escherichia coli (E. coli) that expresses a humanized single-chain
antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked
to ETA(252-608). Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium
is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces
cell death by irreversibly blocking protein synthesis.
In vitro and in vivo pharmacology demonstrated that Vicinium exhibits potent activity
[inhibitory concentration 50% (IC50) = 0.001 - 10 pM] against numerous cell lines and
effectively inhibits tumor growth in several human xenograft animal models. A Phase 2 study
evaluated once-weekly instillations of Vicinium 30 mg over 6 or 12 weeks, followed by up to 3
maintenance cycles (3 once-weekly instillations followed by a 9-week drug-free period) in 45
subjects with histologically-confirmed TCC of the bladder and residual CIS with or without
concurrent Ta or T1 who were refractory or intolerant to BCG. A complete response (defined as
no histological evidence of disease and negative urine cytology at the 3-monthly evaluations)
was achieved by 44% of subjects, and 16% of subjects remained disease-free at 1-year. A
post-study assessment found that these subjects were still disease-free at 18-25 months. The
median time to recurrence was 134 days longer in subjects who received 12 weeks of induction
therapy compared to 6 weeks.
This is an open-label, non-randomized, multicenter study in adults with NMIBC, specifically
CIS (with or without papillary disease), high-grade Ta or any grade T1 papillary disease, who
have previously failed BCG treatment (i.e., not those who are intolerant) with or without
interferon. The study consists of a Screening period, a 12-week Induction Phase, and a
Maintenance Phase of up to 21 monthly cycles for a total treatment period of up to 104 weeks.
This is an outpatient study, but all treatments are administered in the study clinic.
Phase II Randomized Double-Blind Trial of PF-04518600, an OX40 Antibody, in Combination with Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients with Metastatic Renal Cell Carcinoma
Patients with the most common type of kidney cancer are initially treated with VEGF targeting drugs such as sunitinib and pazopanib, among others. Once the cancer develops resistance, the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as nivolumab. Unfortunately, no treatment strategy works forever and inevitably there is a need to change treatment once again. Patients who have had both VEGF targeting drugs and immunotherapy are typically treated with another VEGF targeting agent, although no drug has been found to provide the best outcome in this setting. This study proposes to give such patients axitinib. In addition, this study proposes to investigate whether the addition of an experimental drug, also working on the immune system, would improve the outcomes for patients. Since this is an experiment and the experimental drug is not proven to be effective, half of the patients will receive the experimental drug, i.e. OX40-Ab and the other half will receive placebo. The treatment assignment is decided at random. The OX40-Ab was studied in various cancers and was found to be safe. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) kidney cancer and have been treated with anti PD1/PDL1 immunotherapy in the past, this trial may be a treatment option.
Exercise and Whey Protein Supplementation as Adjunctive Therapy for Patients With Prostate Cancer Receiving Androgen Deprivation Therapy
PRIMARY OBJECTIVES:
I. To determine feasibility of conducting a resistance training (RT) and supplementation
program in this population, determine patient adherence and inter-patient variability, and
estimate the necessary effect sizes for a larger study.
SECONDARY OBJECTIVES:
I. To examine the effects of a high intensity RT program, with and without whey protein
supplement (WPS), on lean body mass (LBM). Enhancing LBM will increase muscle strength,
endurance, and physical function leading to improved quality of life.
TERTIARY OBJECTIVES:
I. To examine the effects of a high intensity RT program with and without WPS on muscle
strength, endurance, physical function, and quality of life.
II. To examine changes in lymphocyte glutathione (GSH) and the pharmacodynamics of WPS with
and without high intensity RT.
OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive whole body
high-intensity RT thrice weekly and whey protein supplementation orally (PO) daily for 12
weeks.
ARM II: Patients receive whole body RT as in Arm I.
ARM III: Patients receive whey protein supplementation as in Arm I.
ARM IV: Patients receive no intervention for 12 weeks. After 12 weeks, patients may receive
whole body RT as in Arm II.
After completion of study treatment, patients are followed up periodically.
A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum
Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes to give pembrolizumab to patients who have had further growth of their cancer after chemotherapy with a platinum agent, according to standard of care, and combine it with an experimental agent, sEphB4-HSA, which may have synergistic effect with pembrolizumab. It is hypothesized that the two drugs, in combination, will be more effective than either drug alone. The sEphB4-HSA was studied in various cancers and was found to be safe with its primary side effect being elevated blood pressure which may require blood pressure medication while receiving the drug. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) bladder cancer (or urothelial carcinoma) and have been treated with platinum-based chemotherapy in the past, this trial may be a treatment option
Not recruiting | Metastatic bladder cancer | Multisite
Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) in advanced/metastatic in patients with
carcinoid or pancreatic islet cell tumors.
SECONDARY OBJECTIVES:
I. To assess overall survival and response rate in advanced/metastatic poor prognosis in
patients with carcinoid or pancreatic islet cell tumors.
II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of
angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Not recruiting | Neuroendocrine Tumors | Multisite
4P-12-1 A Randomized Phase II Trial of Dasatinib plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy
PRIMARY OBJECTIVES:
I. To compare the progression-free survival of men with metastatic castration-resistant
prostate cancer treated with abiraterone (abiraterone acetate) plus dasatinib to that of men
treated with abiraterone alone.
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of the combination, as well as the rate of
prostate-specific antigen (PSA) response, objective responses, and changes in circulating
tumor cell (CTC) numbers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive
abiraterone acetate 1000 mg orally (PO) once daily (QD) and prednisone 5 mg PO twice daily
(BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients receive abiraterone acetate and prednisone as patients in arm A. Patients
also receive dasatinib 100 mg PO QD on days 1-28. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Combined Exercise Program for Early Breast Cancer Survivors
PRIMARY OBJECTIVES:
I. To determine whether a 16-week exercise intervention will improve components of
metastasis (MetS) in breast cancer survivors soon after completion of cancer-related
treatments by measuring changes in body composition, waist circumference, blood pressure,
and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c
(HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in
breast cancer survivors soon after completion of cancer-related treatments by measuring
cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast
cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in
adipose tissue inflammation in obese breast cancer survivors soon after completion of
cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
V. To determine whether breast cancer survivors can maintain positive benefits of an
exercise intervention following a 12-week follow-up period by measuring changes in body
composition, waist circumference, blood pressure, and serum levels of insulin, glucose,
lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes
thrice weekly and are encouraged to participate in a home-based exercise session over 30-45
minutes once weekly for 16 weeks.
Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas
PRIMARY OBJECTIVES:
I. To investigate whether two different radiologists can reliably interpret the following
quantitative criteria regarding the maximally enhancing portion of a soft tissue sarcoma
(STS), on sequential contrast-enhanced ultrasound (CEUS) exams performed before, during, and
after neoadjuvant chemotherapy (NAC): change in peak enhancement (decibels), change in slope
of enhancement curve, and change in area under the curve.
II. To evaluate CEUS as a potential early response assessment biomarker by comparing the
CEUS rating result to computed tomography (CT)/magnetic resonance imaging (MRI) rating
results. (Exploratory) III. To examine the agreement between CEUS versus CT/MRI determined
treatment response within each radiologist rater. (Exploratory) IV. To examine the agreement
between CEUS versus CT/MRI determined treatment response based on the consensus rating
result from the two radiologist raters. (Exploratory) V. To explore potential quantitative
biomarker from all possible parameters that can be extracted from CEUS data for assessing an
early treatment response to neoadjuvant therapy (NAT) in sarcoma using receiver operating
characteristic (ROC) curve when predicting radiologists rated binary outcome: responders
versus non-responders. (Exploratory) VI. To collect preliminary data for shear wave
elastography (SWE) in the same patient population. (Exploratory)
OUTLINE:
Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant
therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery).
After completion of study, patients are followed up at 24 hours.
A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
OBJECTIVES:
Primary
- To compare the sensitivity of multiphase contrast-enhanced CT scan to that of
multiphase contrast-enhanced MRI using non-specific contrast agents for diagnosing
hepatocellular carcinoma (HCC) in patients with chronic liver disease.
Secondary
- To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing
HCC.
- To compare the lesion-level sensitivity and PPV of CT scan and MRI as interpreted by
radiologists at the respective transplant centers.
- To compare the sensitivity and specificity of multiphase contrast-enhanced CT scan vs
MRI for diagnosing residual or recurrent HCC after local ablative therapy in patients
listed for liver transplant.
- To determine the accuracy of imaging-based diagnosis and staging of HCC in clinical
practice using the new Organ Procurement and Transplantation Network (OPTN)
liver-imaging criteria compared with the reference standard of pathologic diagnosis and
staging at the time of explantation.
- To explore whether the comparisons of sensitivity and PPV are affected by stratifying
patients by AFP level (elevated vs normal). (Exploratory)
Tertiary
- To assess the sensitivity and PPV of MRI and CT interpreted at the participating sites
on the basis of all available information and sequences and compare the sensitivity and
PPV of the two modalities interpreted using the main study criterion. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to AFP level
(elevated vs normal).
Patients undergo CT scan with iodinated contrast agent and MRI with extracellular gadolinium
contrast agent (both standard-of-care and study-related) at baseline and at 90-day intervals
while on the liver transplant wait list.
After transplantation, the explanted liver will be analyzed for biomarkers and other
studies.
A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) associated with temozolomide alone or
temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.
SECONDARY OBJECTIVES:
I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and
capecitabine in patients with advanced pancreatic neuroendocrine tumors.
III. To evaluate the toxicity associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by
immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic
neuroendocrine tumor patients treated with either temozolomide or temozolomide and
capecitabine.
V. To bank radiology images for evaluation of quality, reproducibility, and compliance with
computed tomography (CT) methodology.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment
repeats every 28 days for up to 13 courses in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO
QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
and then every 6 months for 3 years.
Not recruiting | Neuroendocrine Tumors | Multisite
A Phase 2 Study of the PARP Inhibitor Olaparib (AZD2281) in IDH1 and IDH2 Mutant Advanced Solid Tumors
PRIMARY OBJECTIVE:
I. To estimate the overall response rates of olaparib in subjects with recurrent/progressive
IDH1/2-mutant solid tumors, who will be recruited to 3 cohorts: a. glioma, b.
cholangiocarcinoma, c. other solid malignant tumors.
SECONDARY OBJECTIVES:
I. To estimate the distribution of progression free survival (PFS) of olaparib in adults with
recurrent/progressive IDH1/2-mutant glioma and cholangiocarcinoma.
II. To estimate the overall survival (OS) in adults with recurrent/progressive IDH1/2- mutant
glioma and cholangiocarcinoma.
III. To determine the duration of response in adults with recurrent/progressive IDH1/2-mutant
glioma, cholangiocarcinoma or other solid malignant tumors.
IV. To confirm the safety and tolerability of olaparib monotherapy.
EXPLORATORY OBJECTIVES:
I. To describe 2HG concentration in plasma by mass spectrometry at baseline and at specific
timepoints and correlate with treatment response.
II. To describe 2HG levels in tumor biopsies from prior to the beginning of treatment and at
specific timepoints and correlate with treatment response.
III. To evaluate in tumor biopsies and in liquid biopsies performed at baseline and at
specific timepoints if co-occurring alterations detected via multiplexed immunofluorescence,
mass cytometry (CyTOF)-imaging mass cytometry (IMC), ribonucleic acid (RNA) sequencing and/or
deoxyribonucleic acid (DNA) sequencing can be associated with differential levels of 2HG
production, treatment response and resistance.
OUTLINE:
Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of AMG 386 (trebananib) 15 mg/kg weekly in
combination with bevacizumab 10 mg/kg every 2 weeks (Cohort 1). (closed to accrual 10/2/12)
II. To assess the efficacy of AMG 386 in combination with bevacizumab 10 mg/kg every 2 weeks
compared to bevacizumab monotherapy in bevacizumab-naïve patients, as measured by 6-month
progression-free survival (PFS6) (Cohort 2).
SECONDARY OBJECTIVES:
I. To further assess the toxicity profile (Cohorts 1 and 2). II. To assess feasibility of
AMG 386 15 mg/kg weekly in combination with bevacizumab 10 mg/kg every 2 weeks (Cohort 1
[closed to accrual 10/2/12]), as measured by the percentage of patients requiring dose
reduction/interruption or discontinuation in the first 2 and subsequent cycles.
III. To determine the radiographic response rate (RR), median progression-free survival
(PFS), and overall survival (OS) in bevacizumab-naïve patients (Cohort 2).
IV. To assess the efficacy of AMG 386 15 mg/kg weekly in combination with bevacizumab 10
mg/kg every 2 weeks in patients who have progressed while on bevacizumab, as measured by
overall survival (OS) (cross-over from placebo arm of Cohort 2).
V. To correlate outcome to treatment with tumor genotype, expression profile, and
circulating angiogenesis biomarkers in tumor specimens (Cohort 2).
VI. To determine the RR, PFS6, and PFS in patients who have progressed while on bevacizumab
therapy and receive AMG 386 in combination with bevacizumab (cross-over from placebo arm of
Cohort 2).
VII. To determine the serum pharmacokinetics of AMG 386 in patients receiving bevacizumab
(Cohort 1 and cross-over from placebo arm of Cohort 2).
OUTLINE: This is a safety study (cohort 1 [closed to accrual 10/2/12]) followed by a
randomized study (cohort 2).
Cohort 1: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and
15 and trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. (closed to accrual
10/2/12)
Cohort 2: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bevacizumab and trebananib as in Cohort 1.
ARM II: Patients receive bevacizumab as in Arm I and placebo IV over 30-60 minutes on days
1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Patients with disease progression may cross over to Arm I.
After completion of study treatment, patients are followed up at 30 days, every 2 months for
1 year, every 6 months for 1 year, and then annually thereafter.
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
OBJECTIVES:
Primary
- To compare disease-free survival of patients with resected stage III colon cancer
treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and
leucovorin calcium with versus without celecoxib.
Secondary
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with these regimens.
- To compare overall survival at 3 years of patients treated with these regimens.
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
- To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients.
- To assess differences in cardiovascular-specific events in patients treated with versus
without celecoxib.
- To evaluate differences in toxicities, particularly cumulative peripheral neuropathy,
in patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to number of
positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs
no). Patients are randomized to 1 of 4 treatment arms.
NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7)
should be stratified to 1-3 nodes.
- Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2
hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients
also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of
FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14
beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the
absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14
days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity.
In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of
disease progression or unacceptable toxicity.
Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for years 2-3, and then annually for 3 years.
Not recruiting | Colon / Rectal Cancer | Multisite
A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
PRIMARY OBJECTIVE:
I. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib
(sorafenib tosylate) in combination with chemoembolization.
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination
with chemoembolization.
II. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine
the rates of toxicity related to sorafenib in combination with chemoembolization.
TERTIARY OBJECTIVES:
I. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including
angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).
II. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network
(ACRIN) secondary imaging objective: site vs. central evaluation of PFS.
III. To determine the inter-reader concordance for response characterization at four and
eight months by the European Association for the Study of Liver (EASL) criteria.
IV. To determine the value of objective tumor response at four and eight months by the EASL
criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.
V. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sorafenib tosylate orally (PO) twice daily (BID) in the absence of
disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose
of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE)
comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of
10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or
chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats
approximately every 4 weeks for up to 4 courses in the absence of disease progression or
unacceptable toxicity.
ARM II: Patients receive placebo PO BID in the absence of disease progression or
unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached,
patients undergo TACE as in Arm I.
MAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib
tosylate or placebo as in Arm I and II in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up for 4 years.
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
OBJECTIVES:
Primary
- To evaluate whether early local therapy comprising surgery of intact primary disease
compared to local palliative therapy only in patients with stage IV breast cancer,
whose disease does not progress during initial optimal systemic therapy, will result in
prolonged survival.
Secondary
- To compare the time to uncontrolled chest wall disease between patients treated with
these regimens.
- To determine whether there is a difference in health-related quality-of-life (HRQOL)
between patients treated with these regimens.
- To determine whether the absolute value of circulating tumor cells (CTC) burden at 6
months following randomization (time +6) will be lower in the palliative therapy arm
than in early local therapy arm, and whether this value is inversely related to
survival (lower CTC, longer survival).
- To collect tumor and blood specimens for future exploration of the biological
interactions between the primary tumor and metastatic lesions and the effect of primary
tumor resection.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor
and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-,
chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of
involved organ systems with distant disease (regional nodes in the axillary,
supraclavicular, and internal mammary locations are not considered distant sites) (1 vs >
1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard palliative therapy, if needed, to address symptoms
such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other
similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a
combination of both.
- Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total
mastectomy according to patient and treating physician preference. Surgery is to occur
no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical
margins must be achieved with re-excision or mastectomy for patients undergoing BCT.
After completion of BCT, patients undergo radiotherapy once a day, 5 days per week.
Patients who had mastectomy undergo radiotherapy at the discretion of treating
physician.
Patients may undergo blood and tumor tissue sample collection for circulating tumor cells
(CTC) burden and future studies.
Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index
(FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life
questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
A Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma
PRIMARY OBJECTIVES:
I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine
(gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as
compared to gemcitabine alone following R0 or R1 resection of head of pancreas
adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase
II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy
following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival
for such patients who are without evidence of progressive disease after 5 cycles of
gemcitabine based chemotherapy. (Phase III)
SECONDARY OBJECTIVES:
I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and
concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who
are disease free after 5 cycles of adjuvant chemotherapy.
II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and
without erlotinib for patients with resected head of pancreas adenocarcinoma.
III. To evaluate adverse events with and without erlotinib for patients with resected head
of pancreas adenocarcinoma.
IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy
and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma
who are disease free after adjuvant chemotherapy.
V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas
adenocarcinoma in order to determine the frequency with which objective criteria of
resectability are present.
VI. To determine if patients reporting low baseline fatigue, as measured by the Functional
Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore
correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement
Information System (PROMIS), and survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days
1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride
orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the
absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib
hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014)
Patients with no disease progression after treatment in arm I or II are then stratified
according to their first randomization treatment arm (arm I vs arm II) and randomized to 1
of 2 additional treatment arms (arm III or IV).
ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II.
ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II.
Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy
(3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week
for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO
twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until
radiotherapy is completed.
After completion of study treatment, patients are followed up periodically.
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
OBJECTIVES:
Primary
- Demonstrate an overall survival (OS) advantage in patients with intermediate-risk
prostate cancer treated with dose-escalated radiotherapy (RT) with versus without
short-term androgen-deprivation therapy (ADT).
Secondary
- Determine whether the addition of ADT to dose-escalated RT versus RT alone improves
clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of
salvage ADT, and prostate cancer-specific mortality in these patients.
- Estimate the magnitude of benefit of ADT with respect to OS in patients treated with
different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate
brachytherapy boost vs high-dose rate brachytherapy boost).
- Compare acute and late treatment adverse events of these regimens and correlate these
events with the presence or absence of pre-existing comorbidity as documented by the
Adult Comorbidity Evaluation 27 assessment.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are
stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs
< 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and
low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments).
Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy
implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at
discretion of treating physician and may include either 3D-conformal RT or
intensity-modulated RT.
- Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone
releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin)
subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy
(flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks
after the first LHRH injection, patients undergo radiotherapy as in arm I.
After completion of study therapy, patients are followed up periodically.
Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
PRIMARY OBJECTIVES:
I. To evaluate disease-free survival with pazopanib (pazopanib hydrochloride) as compared to
placebo, defined as the time from randomization to the development of recurrent disease,
second primary cancer (other than localized breast, localized prostate, or non-melanoma skin
cancer) or death from any cause for patients with metastatic renal cell carcinoma (RCC) with
no evidence of disease following metastasectomy.
SECONDARY OBJECTIVES:
I. To describe the overall survival of patients with advanced RCC randomly assigned to
receive placebo or pazopanib for one year following metastasectomy to no evidence of disease
(NED).
II. To describe treatment and (at recurrence) disease-related adverse events in the two
treatment arms.
III. To analyze quality-adjusted time without symptoms of disease or treatment (Q-TWiST) for
subjects in the two treatment arms.
IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney
cancer-related symptoms during and following treatment with pazopanib compared to placebo.
V. To explore the association between plasma trough levels of pazopanib and disease-free and
overall survival.
VI. To prospectively bank preserved tissue from primary tumors and associated metastatic
sites in patients with RCC.
OUTLINE: Patients are randomized to 1of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28.
Treatment repeats every 28 days for up to 13 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up
to 13 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for the first
two years, every 6 months for the next 3 years, and then annually up to 10 years.
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast
conserving surgery by conventional clinical criteria will provide important information
about the clinical and biologic relevance of occult disease identified by MRI alone.
Patients will be assigned to standard pre-operative breast cancer disease assessment without
the addition of MRI prior to breast conserving surgery or standard pre-operative breast
cancer disease assessment with the use of MRI prior to breast conserving surgery.
The primary objective is to compare the rates of local-regional recurrence (LRR) following
attempted breast conserving therapy in a cohort of women with triple negative or HER-2
amplified breast cancer randomized to preoperative staging with mammography (control arm) or
mammography plus breast MRI (MRI arm).
Secondary objectives are:
- To compare the re-operation rates following attempted breast conserving therapy between
women assessed preoperatively with breast MRI to those assessed without the use of
breast MRI
- To compare local recurrence rates between women who undergo BCT on the control arm to
women who undergo BCT on the MRI arm
- To compare the conversion rate to mastectomy secondary to persistent positive margins
or poor cosmesis within the first 6 months of attempting BCT (prior to the
administration of RT) between women assessed preoperatively with breast MRI to those
assessed without the use of breast MRI
- To compare the contralateral breast cancer rates in women randomized to preoperative
breast MRI to those not receiving pre-operative breast MRI
- To compare the disease-free survival rates between women assessed preoperatively with
breast MRI to those assessed without the use of breast MRI
- To compare breast cancer specific and overall survival outcomes of women assessed
preoperatively with breast MRI to those assessed without the use of breast MRI
- To estimate the rate of MRI-guided localization assisted surgery
- To estimate the rate of multi-centric disease in the index breast for women in the MRI
arm
- To evaluate the accuracy of index lesion characteristics and other factors in
predicting multi-centricity in the cohort randomized to breast MRI
- To assess the positive predictive values (PPV) of MRI in detecting ipsilateral
multi-centric disease and contralateral disease in women with breast cancer undergoing
preoperative breast MRI
- To estimate the false positive rate for detection of multiple foci of breast cancer by
MRI
All registered patients will be monitored for relapse and survival for 5 years from the date
of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from
diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for
local, regional, distant relapse and vital status.
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma
PRIMARY OBJECTIVES:
I. To determine if patients with advanced transitional cell carcinoma treated with
bevacizumab, gemcitabine (gemcitabine hydrochloride) and cisplatin will have increased
overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.
SECONDARY OBJECTIVES:
I. To compare the progression-free survival of these two regimens in patients with advanced
transitional cell carcinoma.
II. To compare the proportion of patients who experience an objective response on each
regimen.
III. To compare the grade 3 and greater toxicities in patients treated on the two regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days
1 and 8, cisplatin IV over 1 hour, and placebo IV over 30-90 minutes on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence
of disease progression or unacceptable toxicity.
ARM II: Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also
receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6
courses in the absence of disease progression or unacceptable toxicity. Patients then
receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 7
years.
Randomized Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) of v-raf murine sarcoma viral oncogene
homolog B (BRAF) mutant metastatic colorectal cancer patients treated with irinotecan
(irinotecan hydrochloride), cetuximab, and vemurafenib, compared to a control arm of
irinotecan and cetuximab.
SECONDARY OBJECTIVES:
I. To evaluate the frequency and severity of toxicity associated with each of the treatment
arms in this patient population.
TERTIARY OBJECTIVES:
I. To evaluate overall survival (OS) in treatment Arms 1 and 2. II. To evaluate the overall
response rate (ORR), including confirmed and unconfirmed, complete and partial response, in
treatment Arms 1 and 2 in the subset of patients with measurable disease.
III. To estimate rates of OS, ORR, and PFS in patients who register to Arm 3 after disease
progression on Arm 1.
IV. To evaluate low-frequency Kirsten rat sarcoma viral oncogene homolog (KRAS) or
neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) mutations as detected by high-depth
sequencing as predictive biomarkers of efficacy.
V. To evaluate phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha
(PIK3CA) pathway activation through PIK3CA mutations or phosphatase and tensin homolog
(PTEN) protein loss as a predictive biomarker of innate resistance to this regimen.
VI. To evaluate gene expression signatures from screened patients with v-raf murine sarcoma
viral oncogene homolog B wild type (BRAFWT) and BRAFV600E tumors.
VII. To provide validation of BRAF immunohistochemistry (IHC) using complementary sequencing
methodology from screened patients with BRAFWT and BRAFV600E tumors.
VIII. To confirm the estimated sensitivity of detectable BRAF V600E circulating cell-free
deoxyribonucleic acid (DNA) as a non-invasive biomarker for BRAF V600E mutation as detected
by IHC in the primary tumor.
IX. To correlate radiographic tumor response with change in quantification of BRAFV600E
alleles in circulating cell-free DNA.
X. To monitor for known mechanism of acquired resistance to epidermal growth factor receptor
(EGFR) inhibition in circulating cell-free DNA (KRAS, NRAS mutations).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cetuximab intravenously (IV) and irinotecan hydrochloride IV on days
1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients with disease progression may cross over to Arm II.
ARM II: Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib
orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2-6 months for 3 years.
Not recruiting | Colon / Rectal Cancer | Multisite
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