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

This is an interventional prevention trial for Precancerous Condition Read More

Criteria:

• Healthy participants at risk for developing melanoma and meeting the following criteria: must have >= 4 large (>= 5 mm and < 15 mm) atypical nevi and have 1 benign nevus amenable to biopsies
• No histologically confirmed melanoma on the baseline biopsy
• No more than 1 prior cutaneous melanoma
• One prior stage I, IIA, or IIB melanoma allowed provided patients have been off treatment > 3 months
• Modified dermoscopy score < 4.8
• Karnofsky performance status 80-100%
• ANC >= 1,500/mm^3
• No family history of melanoma involving >= 2 first degree relatives
• Platelets count >= 100,000/mm^3
• Total bilirubin =< 2.0 mg/dL
• AST/ALT =< 2.0 times upper limit of normal
• Creatinine =< 1.5 mg/dL
• Not pregnant or nursing
• Fertile patients must use effective contraception
• More than 6 months since prior and no concurrent tanning bed use or other methods to promote sun-tanning
• Willing to minimize sunlight exposure by applying sunscreen/sunblock or wearing clothing to shield skin during outdoor activity during study participation
• Willing or able to limit alcohol consumption to less than 3 servings a week during the study period
• No frequent, chronic or moderate/severe gastrointestinal (GI) complaints
• Upper GI problems requiring prescription or nonprescription medical remedies for symptoms of heartburn, dyspepsia, nausea, or abdominal pain > 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