Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma

Phase 2

Completed

• Conditions: Precancerous Condition
• Interventions: Other: placebo; Drug: sulindac; Other: laboratory biomarker analysis

• Registration Number: NCT00841204
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether sulindac is more effective than a placebo in preventing melanoma in individuals with many moles and abnormal moles.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.

SECONDARY OBJECTIVES:

I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.

II. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.

III. To assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants receive oral sulindac twice daily.

ARM II: Participants receive oral placebo twice daily.

In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Blood and tissue samples are collected at baseline and/or after completion of study therapy and analyzed for sulindac and metabolite levels via high performance liquid chromatography tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF expression via immunohistochemistry assays.

After completion of study therapy, participants are followed for 2 weeks.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-14
• Results First Submitted QC: 2012-02-14
• Results First Posted: 2012-03-16
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	Participants receive oral placebo twice daily for 8 weeks
Arm I	laboratory biomarker analysis	Participants receive oral sulindac twice daily for 8 weeks
Arm II	laboratory biomarker analysis	Participants receive oral placebo twice daily for 8 weeks
Arm I	sulindac	Participants receive oral sulindac twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Sulindac Concentration in the Nevi (Moles)	8 weeks
Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi	8 weeks
Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi	8 weeks

Secondary Outcome Measures

Name	Time	Method
Sulindac Effects on Apoptosis in Atypical Nevi	Baseline and 8 weeks	Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component
Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi	Baseline and 8 weeks	Change in VEGF expression in melanocytic junctional component
Association Between Plasma and Target Tissue Sulindac Sulfone Levels	8 weeks
Association Between Plasma and Target Tissue Sulindac Sulfide Levels	8 weeks
Association Between Plasma and Target Tissue Sulindac Levels	8 weeks

Trial Locations

Locations (2)

University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States