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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098969
First received: December 8, 2004
Last updated: December 13, 2012
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: resveratrol
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098969

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE2 7LX
Sponsors and Collaborators
Investigators
Principal Investigator: Dean E. Brenner, MD University of Michigan Cancer Center
  More Information

Additional Information:
Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00098969     History of Changes
Other Study ID Numbers: CDR0000396464, P30CA046592, CCUM-2004-0535, CCUM-2062
Study First Received: December 8, 2004
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014