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A Biological Study of Resveratrol's Effects on Notch-1 Signaling in Subjects With Low Grade Gastrointestinal Tumors

18 Years
Open (Enrolling)
Neuroendocrine Tumor

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Trial Information

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.

Inclusion Criteria:

1. ECOG performance status of 0-2

2. Age >18 years old

3. Women who are not postmenopausal must have a negative enrollment blood test and agree
to use an effective mode of contraception while taking the study medication

4. Greater than four weeks must have elapsed since any previous therapy was administered
for the neuroendocrine tumor, including surgery, radiation, chemotherapy or local
liver therapy.

5. Octreotide use is allowed but must be initiated at least four weeks prior to
enrollment and to the pre-treatment biopsy

6. Able to give informed consent and willing to undergo the post-treatment research

7. Must be able to take oral medications and be without GI tract obstructive symptoms

8. Subjects with another malignancy for which they are either undergoing treatment with
chemotherapy or radiation, or with a malignancy for which such treatments have been
recommended, would be excluded or withdrawn from the study.

9. Must agree to abstain from excessive alcohol, as defined by greater than the
equivalent of three glasses of wine per day or one six pack of beer per day

Exclusion Criteria:

1. The principal investigator will review each subject's current medications prior to
enrollment of the study to ensure that the administration of Resveratrol will not affect
their current medications.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Notch1 activation in post-treatment tumor biopsy specimens when compared to pretreatment levels

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Emily R. Winslow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

July 2014

Related Keywords:

  • Neuroendocrine Tumor
  • gastrointestinal neuroendocrine tumor
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Neuroendocrine Tumors



University of WisconsinMadison,, Wisconsin  53792-5666