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

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: February 10, 2009
Last updated: May 29, 2014
Last verified: March 2013
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.

Condition Intervention Phase
Precancerous Condition Drug: sulindac Other: placebo Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Sulindac Concentration in the Nevi (Moles) [ Time Frame: 8 weeks ]
  • Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ]
  • Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Sulindac Effects on Apoptosis in Atypical Nevi [ Time Frame: 8 weeks ]
  • Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi [ Time Frame: 8 weeks ]
  • Association Between Plasma and Target Tissue Drug Levels [ Time Frame: 8 weeks ]

Enrollment: 50
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Participants receive oral sulindac twice daily for 8 weeks
Drug: sulindac
Given orally
Other Names:
  • Aflodac
  • Algocetil
  • Clinoril
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II
Participants receive oral placebo twice daily for 8 weeks
Other: placebo
Inactive agent
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


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.


I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.

II. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.

III. To assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants receive oral sulindac twice daily.

ARM II: Participants receive oral placebo twice daily.

In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Blood and tissue samples are collected at baseline and/or after completion of study therapy and analyzed for sulindac and metabolite levels via high performance liquid chromatography tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF expression via immunohistochemistry assays.

After completion of study therapy, participants are followed for 2 weeks.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841204

United States, Arizona
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Hsiao-Hui (Sherry) Chow University of Arizona Health Sciences Center
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00841204     History of Changes
Other Study ID Numbers: NCI-2009-01115
NCI-2009-01115 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01CN35158 ( U.S. NIH Grant/Contract )
08-0841-04 ( Other Identifier: University of Arizona Health Sciences Center )
UAZ05-2-10 ( Other Identifier: DCP )
P30CA023074 ( U.S. NIH Grant/Contract )
Study First Received: February 10, 2009
Results First Received: February 14, 2012
Last Updated: May 29, 2014

Additional relevant MeSH terms:
Precancerous Conditions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017