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

Primary Purpose

Neuroendocrine Tumor

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resveratrol

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor focused on measuring gastrointestinal neuroendocrine tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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chemotherapy or radiation, or with a malignancy for which such treatments have been recommended, would be excluded or withdrawn from the study.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 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.

Sites / Locations

University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resveratrol

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Demonstrate that resveratrol at 5 gm per day will be well tolerated with minimal dose limiting toxicities in this patient population.

Frequency of grade three or greater toxicities as defined by the NCI Common Toxicity Criteria.

Describe the effect of resveratrol on tumor growth as demonstrated by standard cross sectional imaging and tumor markers.

The level of tumor markers (eg, chromogranin, 5-HIAA, gastrin, and others) pre-treatment will be compared to the post-treatment levels (collected every three months) as a measure of tumor response. In addition, serial axial imaging will be used to document tumor response rates according to standard Response Evaluation Criteria in Solid Tumors (RECIST).

Full Information

NCT ID

NCT01476592

First Posted

November 9, 2011

Last Updated

November 14, 2019

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01476592

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. The purpose of this study is to examine the effects of resveratrol and Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors who take resveratrol for up to three months tolerate the product.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumor

Keywords

gastrointestinal neuroendocrine tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resveratrol

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Demonstrate that resveratrol at 5 gm per day will be well tolerated with minimal dose limiting toxicities in this patient population.

Description

Frequency of grade three or greater toxicities as defined by the NCI Common Toxicity Criteria.

Time Frame

1 year

Title

Describe the effect of resveratrol on tumor growth as demonstrated by standard cross sectional imaging and tumor markers.

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily R. Winslow, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Links:

URL

https://cancer.wisc.edu/

Description

University of Wisconsin Carbone Cancer Center

Learn more about this trial

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

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