Spots Global Cancer Trial Database for Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy

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Trial Identification

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

Official Title: Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA

Study ID: NCT00305747

Conditions

Prostate Cancer

Interventions

BR-DIM

Study Description

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

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 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.