Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Condition: Precancerous Condition
MeSH terms: Melanoma; Precancerous Conditions
Intervention: sulindac; placebo; laboratory biomarker analysis
Intervention description: Given orally; Inactive agent; Correlative studies
Intervention MeSH terms: Sulindac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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 < 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