2L-14-1 Genomics of Young Lung Cancer Study
I. To perform comprehensive genomic analysis of young lung cancer patients' samples to
facilitate delivery of targeted therapies and clinical trial enrollment.
II. To characterize the impact of young age at lung cancer diagnosis on the genomic
landscape of primary lung cancer.
III. To establish a prospective registry of young lung cancer patients for both tumor and
germline next generation sequencing.
Tissue and blood samples are analyzed via next generation sequencing and whole exome
After completion of study, patients are followed up every 3 months for up to 3 years.
Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
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
1B-12-9: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with Her2 Positive (Her2+) Metastatic Breast Cancer
This is a multicenter, prospective, observational cohort study designed to follow patients with HER2+ MBC (Metastatic Breast Cancer) in the U.S. This observational cohort study (OCS) will provide important longitudinal follow-up of patients with HER2+ breast cancer across various stages to inform treatment strategy decision-making.The primary objective of this OCS is to describe temporal trends in treatment patterns as well as sequencing of treatments and clinical outcomes in patients with metastatic HER2+ breast cancer.A total of approximately 1000 patients will be enrolled out of which 20 will be enrolled at USC. Study duration subsequent to full accrual will be at least 5 years, ensuring a follow up of up to 8 years.Enrolled patients will have an initial diagnosis of HER2+ MBC that has not been previously treated with systemic therapy. They will receive treatment and evaluations for their HER2+ breast cancer as determined by their treating physicians, usually according to the standard of care and clinical practice at each study site.No treatment regimen will be protocol specified, and all treatments that patients receive for their HER2+ breast cancer will be collected. Participants will be asked to complete questionnaires at baseline and periodically throughout the study participation during site visits and at the time of disease progression to assess overall health status, activities of daily living, and other health issues. Patient-reported outcomes will be collected at baseline and periodically throughout study participation.An optional tissue and blood collection will be performed as part of this study.Primary endpoint is distribution of patients receiving unique treatment regimen or sequence of treatment regimens for HER2+ MBC.Secondary endpoints are:1. Progression-free survival (PFS)2. Overall Survival (OS)3. Post-progression survival (PPS) 4. Time to treatment failure (TTF)5. Response rate (RR)For descriptive summaries, continuous variables will be summarized using descriptive statistics. If applicable, analysis of variance (ANOVA)/model (t-test or F-test) or non-parametric testing such as Wilcoxon's rank sum test or Kruskal Wallis test will be used to test group difference on the continuous variables.Categorical variables will be summarized by numbers and proportions. If applicable, chi-square test will be used to test group difference on the categorical variables.
Active, not recruiting | Breast Cancer | Multisite
A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
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
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.
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
GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational
video brochure and watch a 20-minute interactive mindfulness exercise video.
Recruiting | Colon / Rectal Cancer | Not Multisite
Combined Exercise Program for Early Breast Cancer Survivors
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
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
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.
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.
4B-11-4 A Phase I/II Trial of AEZS-108 in Locally Advanced Unresectable or Metastatic LHRH Positive Urothelial Carcinoma Patients who Failed Platinum Based Chemotherapy
AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH),
an hormone and doxorubicin (a drug approved to treat different types of cancer).
Some tumors, such as those found in the urinary system (also called urothelial carcinomas),
have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.
AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have
LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill
them. This would allow the use doxorubicin at lower doses and thus would cause less
In the first part of the study, the appropriate dose of AEZS-108 will be determined based on
its side effects. The best dose will be the highest one without severe side effects.
In the second part of the study, this best dose of AEZS-108 will be given to determine its
efficacy to stop the tumor from progressing.
0S-12-3 18F-FMAU for Imaging in Cancer Patients
Over the past several decades, a greater understanding of tumor biology has resulted in better clinical care and improved survival for many patients with cancer. Advances in imaging techniques, particularly MRI (magnetic resonance imaging) and CT (computed tomography), have improved the detection and staging of tumors, as well as the assessment of response to therapy. Recent advances suggest that it may be feasible to evaluate cell division, one of the most basic processes of tumors, using positron emission tomography (PET). Previous studies using the compound 11C-FMAU with PET imaging have been done to assess its ability to provide a method of imaging tumor cell growth in humans. This study will look at the distribution of FMAU in the body, labeled with Fluoride-18 (18F) rather than 11C due to the increased half life of 18F. The half-life of 11C is 20 minutes, as compared to 109 minutes for 18F. The increased half life of 18F would allow for more delayed imaging and its use by facilities further away from the laboratory where it is produced. We believe that PET imaging using 18F-FMAU will provide an effective method for imaging tumor cell growth in humans. The primary objective of this protocol is to collect preliminary data for the dosimetry (measurement of radiation dose), safety, and tumor uptake of 18F-FMAU in various cancer types and stages. Patients enrolled in this study will have had a clinically indicated volumetric MRI, or FDG PET-CT for the tumor/cancer (over region of known lesion) within 1 month prior to enrollment in the study. Once participants sign the informed consent and are deemed eligible for the study, participants will have the PET procedure with 18F-FMAU injection on Day 1, early stage treatment, and at end of treatment. They will have vital signs taken before injection and following injection. Participants will be monitored for the side effects before leaving the PET clinic and again at 24(+/-2) hours by telephone following FMAU administration to capture side effects. The time point of 18F-FMAU follow-up imaging would be after a few cycles of therapy and it can be scheduled on the day when the patient is coming for a follow-up visit and/or standard of care procedures. 18F-FMAU scans will be compared to available data, such as tumor specific biomarkers, from the participants standard of care procedures, but no specific treatment response criteria will be applied and no sophisticated statistical analysis will be performed.
3R-12-2 Phase II Trial Of Neoadjuvant Bevacizumab With Modified FOLFOX7 In Patients With Stage II And III Rectal Cancer
There were about 40,000 cases of rectal cancer in the United States in 2011. The standard treatment is surgery, but the cancer recurs in 10-20% of cases. To decrease recurrence, chemotherapy and radiation are given before surgery. However, radiation with chemotherapy has not been shown to improve overall survival, so chemotherapy is also given for 3-4 months after surgery. Radiation is also associated with short and long term side effects and has differing effects on survival depending on the stage of disease, but the degree of tumor response after radiation with chemotherapy is associated with survival. Thus, tumor response or complete pathologic response (CPR) appears to be a good indicator for long term outcomes. A previous study has shown that chemotherapy without radiation using FOLFOX (Oxaliplatin, Leukovorin and Fluororacil) and Bevacizumab yields a CPR rate of 27% and does not compromise the removal of the tumor with surgery. This Phase II study will attempt to validate the results of that study using FOLFOX and Bevacizumab without radiation in patients with rectal cancer that has not spread and can be removed surgically. This study will also assess the rate that the tumor recurs and assess specific biomarkers that may be associated with tumor response.Once participants sign the informed consent and are deemed eligible for the study, participants will receive a modified FOLFOX regimen, called mFOLFOX7, with Bevacizumab through a vein in the arm every 2 weeks. Every 2 weeks is called a cycle. During the study, participants will have the following procedures done during each cycle: a physical exam, vital signs, blood tests, performance status, assessment of side effects, review of medications, and tumor assessments with ultrasound and radiographic scans at the end of study treatment before surgery. All participants will stop taking study drug(s) if their disease worsens, they will not have surgery, they have another illness which prevents them from taking the study drug(s), they cannot tolerate the side effects, they withdraw from the study, or their study doctor thinks that being on the study is no longer in their best interest. All participants will be followed every 3 months after stopping the study drug(s) for the first 2 years, and then every 6 months for 3 years.The primary endpoint of this study is complete pathologic response. A two-stage Simon design was used to calculate sample size. All subjects will be analyzed as intent to treat. Biomarkers will be analyzed using a contingency table, bar plots, Fisher's exact test, scatterplots, and two-sample Wilcoxon or t-test. An optimal cut-off value of the continuous biomarker will be chosen to separate patients into 2 groups in term of probability of CPR using the maximal chi-square approach. P value for the associations will be adjusted using bootstrap like simulations.
Recruiting | Colon / Rectal Cancer | Not Multisite
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.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
0C-12-5 An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients with Advanced Refractory Solid Tumors
An open label multicentric Phase 1 study of oral PI3K/mTOR inhibitor P7170 in patients with
advanced refractory solid tumors.The study will follow an Accelerated Titration Design (ATD)
with 100% dose increments until significant toxicity as described below; followed by
standard dose titration with 40% dose increments. Dose and schedule (alternate dosing
regimen eg. OD, BID, intermittent) will be determined by the dose escalation outlined in the
protocol and considering pharmacokinetics of the study drug determined from earlier cohorts.
Suspended | Any Cancer Condition or Solid Tumor | Multisite
Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort
I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention
on cell proliferation in the prostatectomy tissue.
I. To determine the effect of metformin intervention on prostate tissue bioavailability of
II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the
III. To determine the effect of metformin intervention on potential molecular targets of
metformin including activated protein kinase (AMPK) activation, mammalian target of
rapamycin (mTOR) regulation, and cell cycle regulation in the prostatectomy tissue.
IV. To determine the effect of metformin intervention on changes in systemic hormones and
growth factors that have been shown to be modulated by metformin in other patient
populations including fasting glucose, fasting insulin, insulin-like growth factor axis,
testosterone, and sex hormone binding globulin (SHBG).
V. To determine the effect of metformin intervention on changes in prostate-specific antigen
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD)
for 4-12 weeks.
ARM II: Patients receive placebo PO QD for 4-12 weeks.
Patients in both arms undergo surgery one day after completion of treatment.
After completion of study treatment, patients are followed up within 30 days of surgery.