Trial record 1 of 1 for:      Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
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Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00841204
First received: February 10, 2009
Last updated: May 29, 2014
Last verified: March 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sulindac Effects on Apoptosis in Atypical Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Association Between Plasma and Target Tissue Drug Levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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
  • SULIN
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:

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.

SECONDARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841204

Locations
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
Investigators
Principal Investigator: Hsiao-Hui (Sherry) Chow University of Arizona Health Sciences Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00841204     History of Changes
Other Study ID Numbers: NCI-2009-01115, NCI-2009-01115, UARIZ-08-0841-04, CDR0000633938, N01CN35158, 08-0841-04, UAZ05-2-10, P30CA023074, N01CN35158
Study First Received: February 10, 2009
Results First Received: February 14, 2012
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Sulindac
Precancerous Conditions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014