Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 to 65	NCI	UARIZ-08-0841-04 08-0841-04, UARIZ-UAZ05-2-10, NCT00841204

Objectives

Primary

1. Determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.

Secondary

1. Assess the effects of sulindac on apoptosis in atypical nevi of these participants.
2. Assess the effects of sulindac on VEGF expression in atypical nevi of these participants.
3. Assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.

Entry 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

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 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

Patient Characteristics:

• Karnofsky performance status 80-100%
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelets count ≥ 100,000/mm³
• 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 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

Expected Enrollment

Outcomes

Bioavailability of sulindac and its metabolite in target tissue as measured by post-intervention nevus sulindac and sulindac metabolite concentrations

Sulindac effects on apoptosis in atypical nevi
Sulindac effects on VEGF expression in atypical nevi
Association between plasma and target tissue drug levels

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.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

H. H. Sherry Chow, PhD, Protocol chair		Ph: 520-626-3358; 800-622-2673 Email: schow@azcc.arizona.edu
Clara Curiel, MD, Protocol co-chair		Ph: 520-321-7747; 800-622-2673

U.S.A.
Arizona
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
California
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu

Registry Information
Official Title		Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
Trial Start Date		2009-02-10
Trial Completion Date		2010-02-15 (estimated)
Registered in ClinicalTrials.gov		NCT00841204
Date Submitted to PDQ		2009-01-26
Information Last Verified		2009-06-07

Back to Top