NCT00305747

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	BR-DIM	75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects.

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-03-22
• Last updated: 2014-01-15

Locations

2 sites across 1 country: United States