Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 6:22 AM
Study NCT ID:
NCT00098969
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2004-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2012-12-13', 'studyFirstSubmitDate': '2004-12-08', 'studyFirstSubmitQcDate': '2004-12-08', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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.'}, {'pmid': '20935227', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.\n* Correlate dose with systemic concentration of this drug and its metabolites in these participants.\n* Determine the safety of this drug in these participants.\n\nOUTLINE: This is an open-label, dose-escalation, multicenter study.\n\nBeginning 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.\n\nCohorts 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.\n\nParticipants are followed at 2 and 7 days.\n\nPROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy participants\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 80\n\nPerformance status\n\n* WHO 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count \\> 1,500/mm\\^3\n* Platelet count 120,000-450,000mm\\^3\n* Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men\n\nHepatic\n\n* Bilirubin 0.05-1.2 mg/dL\n* AST and ALT \\< 1.5 times normal\n\nRenal\n\n* Creatinine normal\n* Urinalysis normal\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile participants must use effective contraception\n* Willing to abstain from ingesting large quantities of resveratrol-containing foods\n* Willing to spend 24 hours in the hospital\n* 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\n* No concurrent excessive alcohol intake (\\>21 units per week for men; 14 units per week for women)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Concurrent hormone replace ment therapy allowed\n* Concurrent oral or depot contraceptives allowed\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 2 weeks since prior and no concurrent vitamin supplements of any type\n* More than 6 months since prior and no concurrent participation in any other experimental study\n* No other concurrent chronic medications, including over-the-counter medications, herbal/natural preparations, or dietary supplements\n* No other concurrent prescribed medication'}, 'identificationModule': {'nctId': 'NCT00098969', 'acronym': 'IRB 2004-535', 'briefTitle': 'UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424', 'orgStudyIdInfo': {'id': 'CDR0000396464'}, 'secondaryIdInfos': [{'id': 'P30CA046592', 'link': 'https://reporter.nih.gov/quickSearch/P30CA046592', 'type': 'NIH'}, {'id': 'CCUM-2004-0535'}, {'id': 'CCUM-2062'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'resveratrol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109-0942', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': 'LE2 7LX', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Dean E. Brenner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}