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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Precancerous Condition

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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 ...

Detailed Description

PRIMARY OBJECTIVE: I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo. SEC...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2011

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00841204

    Start Date

    February 1 2009

    End Date

    February 1 2011

    Last Update

    December 26 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724

    2

    Stanford University Hospitals and Clinics

    Stanford, California, United States, 94305