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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046592 | U.S. NIH Grant/Contract | View source | |
| CCUM-2004-0535 | |||
| CCUM-2062 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resveratrol | Drug |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Dean E. Brenner, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 20935227 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Leicester Royal Infirmary |
| Leicester |
| England |
| LE2 7LX |
| United Kingdom |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |