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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Healthy participants at risk for developing melanoma and meeting the following
criteria:

- Must have ≥ 4 large (≥ 5 mm and < 15 mm) atypical nevi

- Must 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

- No family history of melanoma involving ≥ 2 first degree relatives

- Modified dermoscopy score < 4.8

PATIENT CHARACTERISTICS:

- Karnofsky performance status 80-100%

- White blood cell count(WBC) ≥ 3,000/mm³

- Absolute neutrophil count (ANC) ≥ 1,500/mm³

- Platelets count ≥ 100,000/mm³

- Total bilirubin ≤ 2.0 mg/dL

- Aspartate aminotransferase (AST)/alanine transaminase (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 including,
but not limited to, any of the following:

- 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 history of bleeding or clotting disorder

- 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 including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

PRIOR CONCURRENT THERAPY:

- At least 3 months since prior and no concurrent coumadin or other systemic
anticoagulant other than aspirin

- At least 30 days since prior participation and no concurrent enrollment or planning
to enroll in another clinical trial

- No non-steroidal anti-inflammatory drugs (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