Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

Inclusion Criteria: * Subjects will be ≥ 18 years. * Subjects will have oral leukoplakia on clinical examination and/or more than one previous HNSCC with dysplasia histologically proven on random biopsy within 6 months at the time of entry. * Patients who have had surgical treatment for a previous HNSCC, stage I-III, will be eligible for enrollment if they are cancer-free ≥ 9 months at the time of entry. Patients with CIS or new leukoplakia will be immediately eligible if they are more then 9 months from treatment of a prior carcinoma. * Leukoplakia lesions must be ≥ 0.5 cm in at least one dimension to be considered measurable. Measurable lesions are not required for entry. * The ECOG performance status will be ≤ 2. (See Appendix B for ECOG performance status.) * The life expectancy will be ≥12 months. * Subjects will have adequate organ function with a platelet count of \>100,000, ANC \> 1500, PT and PTT \< 1.5 X ULN, creatinine \<1.5, urine protein \<2+, and total bilirubin and liver transaminases \<1.5 X ULN. * Premenopausal women will be required to use a reliable method of birth control throughout the course of therapy. * Subjects will provide written, voluntary informed consent Exclusion Criteria: * Patients who have had surgical treatment for a previous HNSCC, stage I-III, will not be eligible for enrollment if they are cancer-free \< 9 months at the time of entry. * Subjects with contraindication to nasopharyngoscopy and biopsy will not be enrolled. * Significant c…