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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00023621 |
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.
Condition | Intervention | Phase |
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Non-Melanomatous Skin Cancer |
Drug: celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome |
Estimated Enrollment: | 60 |
Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms.
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed basal cell carcinoma (BCC)
Meets diagnostic criteria for basal cell nevus syndrome (BCNS)
Any 1 of the following:
Any 2 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
New York, New York, United States, 10032 |
Study Chair: | Ervin Epstein, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068817, UCSF-U19-CA81888-BC, UCSF-H473-16531-02B, NCI-P01-0190 |
Study First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00023621 History of Changes |
Health Authority: | United States: Federal Government |
basal cell carcinoma of the skin |
Anti-Inflammatory Agents Bone Diseases Basal Cell Nevus Syndrome Musculoskeletal Diseases Nevus, Pigmented Bone Cysts Bone Diseases, Developmental Abnormalities, Multiple Neoplasms, Basal Cell Anti-Inflammatory Agents, Non-Steroidal Analgesics Congenital Abnormalities Celecoxib Skin Diseases |
Nevoid Basal Cell Carcinoma Syndrome Cyclooxygenase Inhibitors Carcinoma, Basal Cell Cysts Skin Neoplasms Carcinoma Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Analgesics, Non-Narcotic Peripheral Nervous System Agents Nevus Stomatognathic Diseases Antirheumatic Agents Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Jaw Diseases Jaw Cysts Bone Diseases Odontogenic Cysts Basal Cell Nevus Syndrome Neoplasms by Site Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Bone Cysts Bone Diseases, Developmental Abnormalities, Multiple |
Neoplasms, Basal Cell Anti-Inflammatory Agents, Non-Steroidal Analgesics Congenital Abnormalities Neoplasms by Histologic Type Celecoxib Skin Diseases Cyclooxygenase Inhibitors Enzyme Inhibitors Carcinoma, Basal Cell Cysts Skin Neoplasms Pharmacologic Actions Carcinoma Neoplasms |