Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Male

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 nonmetastatic prostate cancer that has not responded to previous hormone therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: 3,3'-diindolylmethane; Hormones

Criteria

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