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
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
Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer
I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC)
treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA)
decline of >= 50% from baseline.
I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine
in prostate cancer patients.
II. To assess time to radiographic disease progression for patients with recurrent prostate
cancer treated with phenelzine.
III. To collect blood and other samples to study the relationship between MAO activity and
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of
15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been
treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade <
or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating
investigator. Treatment may continue in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up every 3 months for up to 3
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.
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.
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
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
- to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54
weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.
- To compare the overall survival of patients treated with everolimus vs placebo.
- To compare qualitative and quantitative toxicity between the two study arms.
- To bank tissue and biologic specimens for future study of molecular biomarkers relevant
to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and
to investigate their potential predictive and prognostic value.
- To bank blood specimens for the future study of the relationship between steady-state
trough levels of everolimus and relevant side effects (lymphopenia, infection,
hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this
study with everolimus.
OUTLINE: This is a multicenter study.
Patients are stratified according to pathologic stage (intermediate high-risk vs very
high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs
1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every
6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6
weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue, plasma, and whole blood samples may be collected periodically for
biomarker analysis and other translational studies.
After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 8 years.
Active, not recruiting | Kidney Cancer | Multisite
S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
I. To assess the safety of modified leucovorin calcium, fluorouracil, irinotecan
hydrochloride and oxaliplatin (mFOLFIRINOX) in combination with PEGPH20 and select the
optimal dose of PEGPH20 for the phase II portion in patients with metastatic pancreatic
adenocarcinoma. (Phase I) II. To assess the overall survival of patients with metastatic
pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with
mFOLFIRINOX alone. (Phase II)
I. To assess progression free survival (PFS) in patients receiving mFOLFIRINOX with PEGPH20
and patients receiving mFOLFIRINOX alone in this patient population.
II. To assess objective tumor response (confirmed and unconfirmed, complete and partial) in
patients with measurable disease treated with mFOLFIRINOX with PEGPH20 and patients receiving
mFOLFIRINOX alone in this patient population.
III. To determine the frequency, severity, and tolerability of adverse events of mFOLFIRINOX
I. To explore the correlation of maximum decrease in cancer antigen (CA) 19-9 levels and time
to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and
II. To explore the correlation of plasma hyaluronan (HA) and tumor expression of HA with
overall survival, progression-free survival and response.
OUTLINE: This is a phase I, dose de-escalation study of pegylated recombinant human
hyaluronidase followed by a randomized phase II study.
PHASE I: Patients receive pegylated recombinant human hyaluronidase intravenously (IV) over
10 minutes on day 1*; oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2; and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2, and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
ARM II: Patients receive pegylated recombinant human hyaluronidase IV over 10 minutes on day
1* and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil as in Arm
I. Courses repeat every 14 days in the absence of disease progression or unacceptable
*NOTE: Some patients also receive pegylated recombinant human hyaluronidase on day 3 or 4 of
courses 1 and 2.
After completion of study treatment, patients are followed up for 3 years.
Active, not recruiting | Pancreatic Cancer | Multisite
18F-FMAU for Imaging in Cancer Patients
I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse
events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and
characterize the incidence of circulating metabolites of 18F-FMAU in humans.
II. To simply find out whether there is any visual uptake change of 18F-FMAU in tumors
Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer
treatment. Patients may undergo 2 additional scans at one week prior to second course of
chemotherapy and after completion of cancer treatment depending on cancer type.