Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia

Exclusion Criteria

• •The subject has active cancer or carcinoma in situ of the head and neck
• •The subject has a contraindication to biopsy
• •The subject has any history of congestive heart failure, any history of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease
• •The subject exhibits clinical evidence of active liver disease, history of chronic liver disease or edema
• •The subject currently receives insulin, sulfonylurea or metformin (doses of rosiglitazone greater than 4 mg daily in combination with these therapies are not currently indicated; because this protocol uses the maximum recommended dose of 8 mg daily, subjects on insulin, sulfonylurea or metformin will be ineligible for participation in this trial); the subject is currently receiving thiazolidinediones; the subject is a diabetic not on treatment or hyperglycemic (has a random blood glucose level \> 200 mg/dl); the subject has diabetic macular edema
• •The subject is currently receiving medical therapy for dysregulated blood sugar
• •The subject has experienced jaundice with Rezulin® (troglitazone)
• •The subject has known hypersensitivity to rosiglitazone, Avandia, or any of its components
• •The subject has a history of colorectal cancer, familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC)
• •The subject has a history of invasive cancer within the past 18 months (excluding non-invasive bladder cancer, non-melanoma skin cancer and in situ cervical cancer); subjects (excluding those with a history of colorectal cancer, FAP or HNPCC) who received curative treatment and have shown no evidence of recurrence for 18 months will be eligible
• •The subject has had chemotherapy, immunotherapy, hormonal therapy (other than HRT for menopause), or radiation therapy within 18 months of the Baseline visit
• •The subject will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study
• •The subject has received any investigational medication within 30 days of the Baseline visit or is scheduled to receive an investigational drug during the course of the study
• •The subject participated in the study previously and was withdrawn
• •The subject is pregnant or nursing
• •Subjects who have had the study drug prior to this study
• •The subject has uncontrolled intercurrent illness including: ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements