NCT00841204

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

Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Precancerous Condition

Interventions

Type	Name	Description
DRUG	sulindac	Given orally
OTHER	placebo	Inactive agent
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-02-11
• Last updated: 2017-12-26
• Results posted: 2012-03-16

Locations

2 sites across 1 country: United States