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

NCT00023621 | Completed Phase 2

• 4 other identifiers: UCSF-U19-CA81888-BCCDR0000068817UCSF-H473-16531-02BNCI-P01-0190
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

• Prevention of the development of basal cell carcinoma

Interventions

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Tang JY, Wu A, Linos E, Parimi N, Lee W, Aszterbaum M, Asgari MM, Bickers DR, Epstein EH Jr. High prevalence of vitamin D deficiency in patients with basal cell nevus syndrome. Arch Dermatol. 2010 Oct;146(10):1105-10. doi: 10.1001/archdermatol.2010.247.

  PMID: 20956641 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ervin Epstein, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Study Completion: July 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-07

Locations

US (2)