Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
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.
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma|
- Sulindac Concentration in the Nevi (Moles) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Sulindac Effects on Apoptosis in Atypical Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Association Between Plasma and Target Tissue Drug Levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Participants receive oral sulindac twice daily for 8 weeks
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II
Participants receive oral placebo twice daily for 8 weeks
Other Name: PLCBOther: laboratory biomarker analysis
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.
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.
|United States, Arizona|
|University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Stanford University Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Hsiao-Hui (Sherry) Chow||University of Arizona Health Sciences Center|