Prostate Cancer Clinical Trial

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

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.

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Full 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 patients with nonmetastatic, hormone-refractory prostate cancer and rising serum prostate-specific antigen (PSA) levels.
Evaluate the toxicities of BR-DIM.

Secondary

Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population.
Evaluate the effect of BR-DIM supplementation on serum PSA level.
Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation.
Determine quality of life measures in patients taking BR-DIM supplementation.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Quality of life is assessed at baseline, on day 1 of each course, and at the completion of study therapy.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00305747

Recruitment Status:

Completed

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There are 2 Locations for this study

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Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Weisberg Cancer Treatment Center
Detroit Michigan, 48334, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00305747

Recruitment Status:

Completed

Sponsor:


Barbara Ann Karmanos Cancer Institute

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