Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
|ClinicalTrials.gov Identifier: NCT00305747|
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : January 15, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: BR-DIM||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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.
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.
Other Name: oral microencapsulated diindolylmethane
- Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after [ Time Frame: During study and for 30 days after ]
- Plasma pharmacokinetics as measured by occurrences of toxicity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline, day 1 of each cycle and study termination ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305747
|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|