A Biological Study of Resveratrol's Effects on Notch-1 Signaling in Subjects With Low Grade Gastrointestinal Tumors
Patients will be treated with a dose of 5 gm/day of resveratrol orally, in two divided doses
of 2.5 gm each without a break in therapy for a total of three cycles. All patients who
receive at least one dose of resveratrol will be evaluated for toxicity and tolerability.
Toxicities will be assessed every 28 days while the study drug is being taken by the
patient. Pill bottles will be reviewed at this visit as well to ensure compliance with the
study medication. Toxicities will be graded according to the NCI Common Toxicity Criteria.
Blood will be drawn for a complete blood count and comprehensive metabolic panel. In
addition, one vial of serum will be stored at the time of each toxicity assessment for later
analysis of resveratrol levels. This level must be drawn one hour after the morning dose and
the participants will be instructed to alter the time of the morning dose so as to allow
proper timing with the scheduled blood draw.
During the third cycle of treatment, a post-treatment biopsy will be obtained for study
related purposes and will be processed only for research related purposes.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Notch1 activation in post-treatment tumor biopsy specimens when compared to pretreatment levels
1. The investigators aim primarily to show that resveratrol therapy in patients with low-grade GI neuroendocrine tumors will significantly increase Notch1 activation in post-treatment tumor biopsy specimens when compared to pretreatment levels. Endpoints: The primary endpoint will be the level of expression of full length Notch1, cleaved Notch1, HES-1, and ASCL-1, as measured by Western blot using quantitative densitometry. The pre-treatment and post-treatment biopsies will be processed and analyzed simultaneously so as to minimize inter-test variability.
Emily R. Winslow, MD
University of Wisconsin, Madison
United States: Institutional Review Board
|University of Wisconsin||Madison,, Wisconsin 53792-5666|