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Phase II Randomized Study of Celecoxib for Chemoprevention of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Prevention
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Completed
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18 to 75
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NCI
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UCSF-U19-CA81888-BC UCSF-H473-16531-02B, NCI-P01-0190, NCT00023621
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Objectives - Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy: 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: Surgery: 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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC greater than 3,000/mm3
- Platelet count greater than 125,000/mm3
- 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
Expected Enrollment 60A total of 60 patients (30 per arm) will be accrued for this study. Outcomes Primary Outcome(s)Prevention of the development of basal cell carcinoma
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.
Trial Contact Information
Trial Lead Organizations UCSF Helen Diller Family Comprehensive Cancer Center | | | Ervin Epstein, MD, Protocol chair(Contact information may not be current) | | | |
Registry Information | | Official Title | | A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects with Basal Cell Nevus Syndrome | | Trial Start Date | | 2001-02-06 | | Registered in ClinicalTrials.gov | | NCT00023621 | | Date Submitted to PDQ | | 2001-06-15 | | Information Last Verified | | 2007-07-03 | | NCI Grant/Contract Number | | CA82103, CA81888 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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