Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00313534|
Recruitment Status : Terminated (Ran out of drug)
First Posted : April 12, 2006
Last Update Posted : October 11, 2012
RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: masoprocol||Phase 1|
- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.
- Determine prostate-specific antigen-modulating effects of NDGA in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Official Title:||A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
- Dose-limiting toxicity as measured by CTC v3.0
- Maximum tolerated dose
- Prostate-specific antigen (PSA) at baseline and on day 1 of each course
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313534
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Charles Ryan, MD||University of California, San Francisco|