A Phase IIa Cancer Prevention Trial of the PPAR Gamma Agonist Pioglitazone in Oral Leukoplakia
I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in
patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia.
I. Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 12 weeks in the
absence of disease progression, unacceptable toxicity, or the development of carcinoma.
Patients are followed up at 4, 8, 12, and 16 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Patients' Overall Response
Overall Response= reviewing both the clinical and histological responses and assigning the worst category. Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD
Week 16 (4 weeks post dose)
University of Minnesota Medical Center-Fairview
United States: Institutional Review Board
|University of Minnesota Medical Center-Fairview||Minneapolis, Minnesota 55455|