Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

Criteria: ECOG 0-2 Diagnosis of oral cavity or oropharyngeal leukoplakia meeting 1 of the following criteria: Biopsy-proven hyperplasia in high-risk anatomic areas (e.g., floor of the mouth, mobile tongue, oropharynx, or in any erythroplakia lesion) Mild, moderate, or severe dysplasia at any site of the oral cavity or oropharynx within the lesion Measurable lesion that is clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia Able to be assessed by bi-directional measurements Life expectancy: More than 3 months Hemoglobin >= lower limit of normal for males and post-menopausal females OR Hemoglobin >= 11 g/dL for premenopausal females WBC > 3,000/mm^3 Hepatic: Bilirubin < 1.5 times upper limit of normal (ULN); AST and ALT < 1.5 times ULN Renal: BUN < 1.5 times ULN; Creatinine < 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No contraindication to thiazolidinediones No allergy to pioglitazone or other thiazolidinediones No serious oral infection No invasive carcinoma within the past 60 months except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent malignancy More than 3 months since prior biologic or immunologic therapy No concurrent insulin for diabetes No prior radiotherapy to the oral cavity More than 3 months since prior chemopreventative agents More than 3 months since prior experimental therapy More than 3 months since prior megadose vitamins or alternative therapy No prior thiazolidinediones No prior participation in this study No concurrent pharmacologic treatment for diabetes Concurrent chronic use of non-steroidal anti-inflammatory drugs allowed Platelet count > 125,000/mm^3 Index lesion must be located in an anatomic site accessible by punch biopsy