Genitourinary Clinical Trials

Trial MenuList of Available Trials:

 

 

Available only through CTSU Registration

CALGB-70807: “The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance”

Outline:
This is a multicenter study. Patients are stratified according to age (≤ 70 years vs. > 70 years), race (African American vs. other), and time of baseline prostate biopsy (0-12 months before registration vs. > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms.

Arm I:
Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.

Arm II:
Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies. Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months.  After study entry, patients are followed up every 3 months for 2 years.

Disease Characteristics:

  • Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to presentation
    • < 25% of biopsy tissue cores positive for cancer

    • ≤ 50% of any one biopsy tissue core positive for cancer
       
  • Clinical stage ≤ T2a

  • Patients who have prostate cancer with distant metastases are not eligible

  • For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7

  • Serum PSA < 10 ng/mL
    • Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
       
  • Patients are offered registration to the correlative study CALGB-151105

Prior/Concurrent Therapy:

  • Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy are not eligible

  • Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible

  • Patients who are currently taking coumadin are not eligible

  • Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as measured by the run-in dietary recalls, are not eligible

  • Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior to preregistration are not eligible

Patient Characteristics:

  • Life expectancy of at least 3 years

  • Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone

  • Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible

  • Successful completion of three 24-hour dietary recalls during the run-in period

the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase.

Primary Outcome(s)

Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year)

Secondary Outcome(s)

  • Progression defined by PSADT and time to progression
  • Time to treatment
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months

National Enrollment to Date: 284/464

Available only through CTSU Registration

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SWOG S0931: “EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.”

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.

ELIGIBILITY:
Ambulatory, early stage (I or II) breast and prostate cancer survivors who are at least two years out of treatment (excluding hormonal therapy) with no severe co-morbid DISEASE

CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma
  • Clear cell or non-clear cell allowed
  • No disease of the collecting duct or medullary carcinoma
  • Considered pathologically either intermediate high-risk or very high-risk disease
  • No history of distant metastases
  • Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
  • Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
  • Surgical margins must be negative
  • Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
  • Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
  • No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
  • MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
  • Bilirubin ≤ 1.5 times ULN
  • SGOT and SGPT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
  • Able to take oral medications
  • Patients must not have any of the following:
  • NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
  • Unstable angina pectoris
  • Myocardial infarction within the past 6 months
  • Serious uncontrolled cardiac arrhythmia
  • Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
  • HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
  • Must be able to take oral medications
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • No known history of HIV seropositivity
  • No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
  • No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
  • Optimal lipid control must be achieved before registration and monitored during protocol treatment
  • No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
  • Optimal glucose control must be achieved before registration and monitored during protocol treatment
  • No prior malignancies except for any of the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
  • Any other cancer from which the patient has been disease-free for 5 years
  • No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
  • No contraindications to receiving either IV iodine-based contrast or gadolinium


PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients must have recovered from any surgery-related complications
  • No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
  • More than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)
  • More than 7 days since prior and no concurrent live vaccines
  • No other concurrent anticancer agents including investigational agents
  • No concurrent chronic treatment with systemic steroids or another immunosuppressive agent

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.
  • Topical or inhaled corticosteroids are allowed

National Enrollment to Date:  592/1170

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