Phase 2 N=50 Randomized Double-blind Prevention

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

Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00841204 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Mar 2012

Primary outcome: Primary: Sulindac Concentration in the Nevi (Moles) — 0.51; 0 µg/g tissue

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sulindac (Drug); placebo (Other); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Sulindac Concentration in the Nevi (Moles)	0.51; 0	—
PRIMARY Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi	1.38; 0	—
PRIMARY Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi	0.12; 0	—
SECONDARY Sulindac Effects on Apoptosis in Atypical Nevi	3; -25	0.0056 sig
SECONDARY Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi	23; 0	0.386
SECONDARY Association Between Plasma and Target Tissue Sulindac Levels	0.41	<0.05 sig
SECONDARY Association Between Plasma and Target Tissue Sulindac Sulfone Levels	0.13	0.58
SECONDARY Association Between Plasma and Target Tissue Sulindac Sulfide Levels	0.33	0.12

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.

Eligibility Criteria

Criteria:

Healthy participants at risk for developing melanoma and meeting the following criteria: must have >= 4 large (>= 5 mm and 3 months
Modified dermoscopy score = 1,500/mm^3
No family history of melanoma involving >= 2 first degree relatives
Platelets count >= 100,000/mm^3
Total bilirubin = once a week on average
History of peptic ulcer, occult or gross intestinal bleeding
No prior allergic reaction to aspirin (unless subsequent dosing with other NSAIDs has been well tolerated)
No history of allergic reaction to lidocaine or xylocaine
No history of allergic reaction (e.g., urticaria, asthma, or rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
No invasive cancer or cancer treatment within the past 5 years, except nonmelanoma skin cancer
No immunosuppression by medication or disease, including any of the following: AIDS, oral prednisone, immunosuppressant/immunomodulator (i.e., cyclosporine, chemotherapeutic agent, or biologic therapy)
No uncontrolled intercurrent illness
No ongoing or active infection
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No psychiatric illness/social situations that would limit compliance with study requirements
At least 30 days since prior participation and no concurrent enrollment or planning to enroll in another clinical trial
No NSAIDs for more than 5 days per month within the past 3 months and no concurrent non-study NSAIDs, except low dose aspirin (81 mg/day)
Willing or able to refrain from herbal medicines, above-standard vitamins, or minerals during study
Standard daily multivitamin/mineral supplement (i.e., therapeutic doses of calcium and vitamin D for osteoporosis) allowed
No concurrent lithium, phenytoin, or sulfonamides
WBC >= 3,000/mm^3
No history of bleeding or clotting disorder
At least 3 months since prior and no concurrent coumadin or other systemic anticoagulant other than aspirin

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Data sourced from ClinicalTrials.gov (NCT00841204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.