Glioblastoma Multiforme Clinical Trial
Official title:
Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction
caused by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone
hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with
brain tumors.
PRIMARY OBJECTIVE:
I. To evaluate the tolerability and toxicity associated with two different dose regimens of
pioglitazone administered orally as a cytoprotective agent against radiation-induced brain
injury.
SECONDARY OBJECTIVE:
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
patients.
OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal
radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone
hydrochloride once daily before for 1 week prior to brain irradiation, during and and
continuing for 6 months after completion of radiation radiotherapy. After completion of study
treatment, patients are followed periodically.
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