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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023621 |
Purpose
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 |
|---|---|---|
|
Non-melanomatous Skin Cancer |
Drug: celecoxib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | University of California, San Francisco |
More Information
| ClinicalTrials.gov Identifier: | NCT00023621 History of Changes |
| Other Study ID Numbers: | CDR0000068817, UCSF-U19-CA81888-BC, UCSF-H473-16531-02B, NCI-P01-0190 |
| Study First Received: | September 13, 2001 |
| Last Updated: | November 4, 2010 |
| Health Authority: | United States: Federal Government |
|
basal cell carcinoma of the skin |
|
Basal Cell Nevus Syndrome Skin Neoplasms Carcinoma, Basal Cell Odontogenic Cysts Jaw Cysts Bone Cysts Cysts Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplastic Syndromes, Hereditary Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Jaw Diseases Stomatognathic Diseases Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Neoplasms by Site Skin Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal |