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