Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
I. Determine sulindac and sulindac metabolites (sulindac sulfone and sulindac sulfide)
levels in healthy participants with atypical nevi (abnormal moles) and benign nevus at
increased risk for melanoma treated with sulindac versus placebo.
I. Assess the effects of sulindac on apoptosis in atypical nevi of these participants.
II. Assess the effects of sulindac on vascular endothelial growth factor (VEGF) expression
in atypical nevi of these participants.
III. 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.
- Sulindac arm: Participants receive oral sulindac 150 mg twice daily.
- Placebo arm: 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 expression of the marker of apoptosis, cleaved caspase 3, and
VEGF in atypical nevi was determined via immunohistochemistry assays.
After completion of study therapy, participants are followed for 2 weeks.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Sulindac Concentration in the Nevi (Moles)
H. H. Sherry Chow, PhD
University of Arizona
United States: Federal Government
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|Stanford Cancer Center||Stanford, California 94305-5824|