UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants (IRB 2004-535)

December 13, 2012 updated by: National Cancer Institute (NCI)

Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leicester, England, United Kingdom, LE2 7LX
        • Leicester Royal Infirmary
  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dean E. Brenner, MD, University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Registration Dates

First Submitted

December 8, 2004

First Submitted That Met QC Criteria

December 8, 2004

First Posted (Estimate)

December 9, 2004

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000396464
  • P30CA046592 (U.S. NIH Grant/Contract)
  • CCUM-2004-0535
  • CCUM-2062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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