Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA|
- Maximum tolerated dose during study and for 30 days after [ Designated as safety issue: Yes ]
- Dose limiting toxicity during study and for 30 days after [ Designated as safety issue: Yes ]
- Toxicity during study and for 30 days after [ Designated as safety issue: Yes ]
- Plasma pharmacokinetics as measured by occurrences of toxicity at baseline, 20, 60, 120, 180, 240, and 480 minutes [ Designated as safety issue: Yes ]
- Serum prostate specific antigen as measured by complete plasma concentration-time profile at baseline, day 1 of each course, and at study termination [ Designated as safety issue: No ]
- Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level at baseline, second course, and study termination [ Designated as safety issue: No ]
- Quality of life (QOL) by Life Orient. Test-Rev., Duke-UNC Func. Social Support Questionnaire, EORTC QOL questionnaire, QLQ-PR25 questionnaire, and the Hosp. Anxiety & Depression Scale at baseline, day 1 of each course, and study termination [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Weisberg Cancer Treatment Center|
|Detroit, Michigan, United States, 48334|
|Study Chair:||Elisabeth I. Heath, MD||Barbara Ann Karmanos Cancer Institute|