Status:
COMPLETED
Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetas...
Detailed Description
OBJECTIVES: Primary * Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase II dose of absorption-enhanced diindolylmethane (BioResponse-DIM\^® \[BR-DIM\]) in patient...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the prostate
- Prostate specific antigen (PSA)-only failure after local therapy (surgery, radiation therapy, brachytherapy, or cryotherapy)
- Rising PSA despite androgen-deprivation therapy with castrate levels of testosterone (\< 50 ng/dL)
- Two successive rising PSA levels at least 1 week apart
- PSA ≥ 5 ng/mL
- Patients with a history of combined hormonal therapy must continue luteinizing-hormone releasing-hormone agonist treatment but must demonstrate rising PSA after anti-androgen withdrawal
- No evidence of distant metastasis by bone scan and CT scan
- No known brain metastases requiring active therapy
- PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 3
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal
- Creatinine clearance ≥ 60 mL/min OR creatinine normal
- Fertile patients must use effective contraception
- None of the following conditions within the past 6 months:
- Myocardial infarction
- Severe or unstable angina
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Coronary/peripheral artery bypass grafting
- No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior radiotherapy
- At least 28 days since prior investigational agents for treatment of prostate cancer
- At least 4 weeks since prior flutamide
- At least 6 weeks since prior bicalutamide
- No other concurrent antineoplastic agents
- No concurrent warfarin-related anticoagulants
- No concurrent proton-pump inhibitor drugs for gastroesophageal reflux disease (e.g., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
- No concurrent micronutrient supplements or dietary soy products
- One daily multivitamin allowed
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00305747
Start Date
August 1 2005
End Date
September 1 2010
Last Update
January 15 2014
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
Weisberg Cancer Treatment Center
Detroit, Michigan, United States, 48334