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

Not Recruiting

Trial ID: NCT00841204


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.

Official Title

Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma

Stanford Investigator(s)

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology



   - 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

   - 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

   - 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


drug: Sulindac

other: laboratory biomarker analysis

other: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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