Status:
COMPLETED
A Biological Study of Resveratrol's Effects on Notch-1 Signaling in Subjects With Low Grade Gastrointestinal Tumors
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth of tumors in mice. ...
Detailed Description
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 on...
Eligibility Criteria
Inclusion
- ECOG performance status of 0-2
- Age \>18 years old
- 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
- 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.
- Octreotide use is allowed but must be initiated at least four weeks prior to enrollment and to the pre-treatment biopsy
- Able to give informed consent and willing to undergo the post-treatment research biopsy
- Must be able to take oral medications and be without GI tract obstructive symptoms
- 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chemotherapy or radiation, or with a malignancy for which such treatments have been recommended, would be excluded or withdrawn from the study.
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01476592
Start Date
December 1 2011
End Date
October 11 2018
Last Update
November 18 2019
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792