Phase I Study to Determine Safety of Pioglitazone Combined With Radiation Therapy in Subjects With Brain Tumors
I. To evaluate the tolerability and toxicity associated with two different dose regimens of
pioglitazone (pioglitazone hydrochloride) administered orally as a cytoprotective agent
against radiation-induced brain injury.
I. To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when
pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic
OUTLINE: This is a dose escalation study of pioglitazone hydrochloride.
Patients undergo fractionated external beam radiotherapy. Beginning one day before
radiotherapy, patients receive pioglitazone hydrochloride orally (PO) 5 days per week,
continuing throughout radiotherapy and then for 6 months after completion of radiotherapy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Tolerability and toxicity, measured by incidence of dose limiting toxicities (DLT)
A DLT is defined as: 1) Common Toxicity Criteria (CTC) 3.0 Grade III weight gain, 2) Measurement and Grading of Peripheral Extremity Edema Scale Grade III edema, 3) CTC 3.0 Grade III hypoglycemia and 4) New York Heart Association (NYHA) Classification of Heart Failure Grade III symptoms of heart failure. Toxicity rates and exact 95% confidence intervals will be calculated separately for each dose level.
Up to 30 days after the last treatment of radiotherapy
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|