Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma. PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.

Detailed Description
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OBJECTIVES: Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms. Arm I: Patients receive oral celecoxib twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in the absence of unacceptable toxicity. Patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.

Official Title
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A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed basal cell carcinoma (BCC) At least 5 prior BCCs AND At least 4 BCCs within the past year Meets diagnostic criteria for basal cell nevus syndrome (BCNS) Any 1 of the following: More than 2 BCCs or 1 before age 20 Histologically confirmed odontogenic keratocysts of the jaw 3 or more palmar and/or plantar pits Bilamellar calcification of the falx cerebri (if less than 20 years of age) Fused, bifid, or markedly splayed ribs First degree relative with BCNS PTC gene mutation in normal tissue OR Any 2 of the following: Macrocephaly determined after adjustment for height Congenital malformations (e.g., cleft lip or palate, frontal bossing, coarse face, or moderate or severe hypertelorism) Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits) Radiological abnormalities (e.g., bridging of the sella turcica, vertebral anomalies, modeling defects of the hands and feet, or flame-shaped lucencies of the hands or feet) Ovarian fibroma Medulloblastoma PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 125,000/mm^3 Hemoglobin greater than 12.0 g/dL (women) Hemoglobin greater than 13.0 g/dL (men) No significant coagulation defect Hepatic: Bilirubin normal ALT/AST no greater than 1.5 times upper limit of normal (ULN) No chronic or acute hepatic disorder Renal: Creatinine no greater than 1.5 times ULN BUN normal Electrolytes within normal No chronic or acute renal disorder Cardiovascular: No congestive heart failure Gastrointestinal: No active gastrointestinal disease No inflammatory bowel disease No chronic or acute pancreatic disorder No history of gastrointestinal ulceration allowed except with permission of primary care physician No esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days Stool hematest normal Other: No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer, stage I cervical cancer, stage 0 chronic lymphoblastic leukemia, or medulloblastoma No hypersensitivity to COX-2 inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides No other condition that would preclude study involvement Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior topical agents as chemoprevention At least 1 year since other prior chemotherapy Endocrine therapy: At least 1 month since prior oral or IV corticosteroids At least 6 months since prior inhaled corticosteroid use for longer than 4 weeks At least 2 weeks since prior topical glucocorticoids No concurrent topical glucocorticoids Concurrent oral and IV corticosteroid use of less than 2 weeks within 6 months allowed Concurrent inhaled corticosteroid use of less than 4 weeks within 6 months allowed Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior topical retinoids or alpha-hydroxy acids (e.g., glycolic acid or lactic acid) At least 2 weeks since prior topical medications At least 30 days since prior investigational agents At least 2 months since prior NSAIDs given more than 3 times/week At least 2 months since prior aspirin dose of more than 100 mg/day given more than 3 times/week At least 6 months since prior oral retinoids No concurrent chronic NSAIDs (more than 3 times per week for at least 2 weeks) No concurrent aspirin dose of more than 100 mg/day No concurrent topical medications No concurrent fluconazole No concurrent lithium No concurrent retinoids (including topical administration) or alpha-hydroxy acids No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of the development of basal cell carcinoma |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma of the skin