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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Collaborator: |
University of Arizona |
| Information provided by (Responsible Party): | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00841204 |
Purpose
RATIONALE: 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Precancerous Condition |
Drug: sulindac Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Drug: sulindac
Given orally
|
|
Placebo Comparator: Arm II
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Other: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.
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 |
DISEASE CHARACTERISTICS:
Healthy participants at risk for developing melanoma and meeting the following criteria:
No more than 1 prior cutaneous melanoma
PATIENT CHARACTERISTICS:
No frequent, chronic or moderate/severe gastrointestinal (GI) complaints including, but not limited to, any of the following:
No immunosuppression by medication or disease, including any of the following:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Willing or able to refrain from herbal medicines, above-standard vitamins, or minerals during study
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, California | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| Study Chair: | H. H. Sherry Chow, PhD | University of Arizona |
| Principal Investigator: | Clara Curiel, MD | University of Arizona |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00841204 History of Changes |
| Other Study ID Numbers: | CDR0000633938, P30CA023074, UARIZ-08-0841-04 |
| Study First Received: | February 10, 2009 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Federal Government |
|
precancerous condition |
|
Disease Melanoma Precancerous Conditions Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Sulindac Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |