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Tracking Information | |||||
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First Received Date † | March 21, 2006 | ||||
Last Updated Date | August 26, 2008 | ||||
Start Date † | August 2005 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00305747 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy | ||||
Official Title † | Phase I Study of Bioresponse-Dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA | ||||
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. |
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Detailed Description | 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Prostate Cancer | ||||
Intervention † | Drug: oral microencapsulated diindolylmethane | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 36 | ||||
Completion Date | |||||
Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00305747 | ||||
Responsible Party | |||||
Secondary IDs †† | WSU-D-2979, WSU-0507002581 | ||||
Study Sponsor † | Barbara Ann Karmanos Cancer Institute | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |