Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
- Registration Number
- NCT00305747
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BR-DIM BR-DIM BR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after During study and for 30 days after
- Secondary Outcome Measures
Name Time Method Plasma pharmacokinetics as measured by occurrences of toxicity At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes Serum prostate specific antigen as measured by complete plasma concentration-time profile At baseline, Day 1 of each cycle and at study termination Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level At baseline, Cycle 2 and study termination 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 cycle and study termination
Trial Locations
- Locations (2)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Weisberg Cancer Treatment Center
🇺🇸Detroit, Michigan, United States