Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Summary
RATIONALE: 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.
PURPOSE: This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma.
Description
OBJECTIVES:
Primary
- 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
- Assess the effects of sulindac on apoptosis in atypical nevi of these participants.
- Assess the effects of sulindac on VEGF expression in atypical nevi of these participants.
- 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 Design
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Precancerous Condition
Intervention
sulindac, placebo
Location
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson
Arizona
United States
85724-5024
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00841204
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leukoplakia
A white patch lesion found on a MUCOUS MEMBRANE that cannot be scraped off. Leukoplakia is generally considered a precancerous condition, however its appearance may also result from a variety of HEREDITARY DISEASES.
Precancerous Conditions
Pathological processes that tend eventually to become malignant. (From Dorland, 27th ed)
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Sulindac
A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.
Clinical Trials
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PubMed Articles
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The European Pharmacopoeia describes a liquid chromatography (LC) method for the quantification of sulindac, using a quaternary mobile phase including chloroform and with a rather long run time. In th...
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An old dog with new tricks! While sulindac, a nonsteroidal anti-inflammatory drug (NSAID), has been extensively investigated as an anticancer agent, its mechanism of action remains poorly understood....
