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

NCT00841204 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-01115UARIZ-08-0841-04CDR0000633938N01CN3515808-0841-04UAZ05-2-10P30CA023074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Precancerous Condition

Outcome Measures

Primary Outcomes (3)

• Sulindac Concentration in the Nevi (Moles)

  8 weeks

• Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi

  8 weeks

• Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi

  8 weeks

Secondary Outcomes (5)

• Sulindac Effects on Apoptosis in Atypical Nevi

  Baseline and 8 weeks

• Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi

  Baseline and 8 weeks

• Association Between Plasma and Target Tissue Sulindac Levels

  8 weeks

• Association Between Plasma and Target Tissue Sulindac Sulfone Levels

  8 weeks

• Association Between Plasma and Target Tissue Sulindac Sulfide Levels

  8 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Participants receive oral sulindac twice daily for 8 weeks

Drug: sulindac; Other: laboratory biomarker analysis

Arm II

PLACEBO COMPARATOR

Participants receive oral placebo twice daily for 8 weeks

Other: placebo; Other: laboratory biomarker analysis

Interventions

sulindac DRUG

Given orally

Also known as: Aflodac, Algocetil, Clinoril, SULIN

Arm I

placebo OTHER

Inactive agent

Also known as: PLCB

Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Precancerous Conditions

Interventions

Sulindac

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: H-H. Sherry Chow, Ph.D.
• Organization: The University of Arizona

schow@azcc.arizona.edu

520-626-3358

Study Officials

• Hsiao-Hui (Sherry) Chow

  University of Arizona Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 26, 2017
• Results First Posted: March 16, 2012

Record last verified: 2017-11

Locations

US (2)