UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
NCT ID: NCT00098969
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2004-09-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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PREVENTION
NONE
Interventions
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resveratrol
Eligibility Criteria
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Inclusion Criteria
* Healthy participants
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count 120,000-450,000mm\^3
* Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men
Hepatic
* Bilirubin 0.05-1.2 mg/dL
* AST and ALT \< 1.5 times normal
Renal
* Creatinine normal
* Urinalysis normal
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile participants must use effective contraception
* Willing to abstain from ingesting large quantities of resveratrol-containing foods
* Willing to spend 24 hours in the hospital
* No cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years except basal cell or squamous cell skin cancer
* No concurrent excessive alcohol intake (\>21 units per week for men; 14 units per week for women)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Concurrent hormone replace ment therapy allowed
* Concurrent oral or depot contraceptives allowed
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 2 weeks since prior and no concurrent vitamin supplements of any type
* More than 6 months since prior and no concurrent participation in any other experimental study
* No other concurrent chronic medications, including over-the-counter medications, herbal/natural preparations, or dietary supplements
* No other concurrent prescribed medication
18 Years
80 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Dean E. Brenner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Leicester Royal Infirmary
Leicester, England, United Kingdom
Countries
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References
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Boocock DJ, Gescher AJ, Brown V, et al.: Phase I single-dose safety and pharmacokinetics clinical study of the potential cancer chemopreventive agent resveratrol. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. 2006.
Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.
Other Identifiers
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CCUM-2004-0535
Identifier Type: -
Identifier Source: secondary_id
CCUM-2062
Identifier Type: -
Identifier Source: secondary_id
CDR0000396464
Identifier Type: -
Identifier Source: org_study_id