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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305747 |
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 | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: oral microencapsulated diindolylmethane |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of Bioresponse-Dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA |
Estimated Enrollment: | 36 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Rising PSA despite androgen-deprivation therapy with castrate levels of testosterone (< 50 ng/dL)
PATIENT CHARACTERISTICS:
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
No concurrent micronutrient supplements or dietary soy products
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 |
Study ID Numbers: | CDR0000462637, WSU-D-2979, WSU-0507002581 |
Study First Received: | March 21, 2006 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00305747 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage I prostate cancer stage II prostate cancer |
stage III prostate cancer adenocarcinoma of the prostate stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |