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Brief Title: Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia
Official Title: Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
Study ID: NCT00052611
Brief Summary: Patient at increased risk for developing a new head and neck squamous cell carcinoma are invited to take part in this study. The investigators of this trial will attempt to study the effectiveness of Celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.
Detailed Description: Celecoxib is being studied in precancerous lesions of the head and neck in part because, it has been shown to prevent the progression of another type of precancerous polyps (a type of abnormal growth) in patients at high risk for colorectal cancer. There are, however, no published studies yet looking at this drug in humans for the prevention of head and neck cancers. The U.S. Food and Drug Administration has approved celecoxib for arthritis and the prevention of polyps in patients with familial adenomatous polyposis (a type of precancerous syndrome in some families that can lead to colon cancer). This study is being done to find out several things: * Is celecoxib, also known by the trade name Celebrex ®, effective in reducing the expression of precancerous markers (biological signals for specific cellular activities) in oral leukoplakia and dysplasia (abnormal growth) of the oral mucosa? * Is celecoxib effective in reducing the size of oral leukoplalda lesions and/or presence of dysplasia? * Does the reduction in precancerous markers correspond with reduction of oral leukoplalda and/or presence of dysplasia? * What are the side effects of celecoxib in this patient population?
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Name: Lori J. Wirth, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR