UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants (IRB 2004-535)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: resveratrol||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424|
|Study Start Date:||September 2004|
- Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
- Correlate dose with systemic concentration of this drug and its metabolites in these participants.
- Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098969
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE2 7LX|
|Principal Investigator:||Dean E. Brenner, MD||University of Michigan Cancer Center|