Spots Global Cancer Trial Database for Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors

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Trial Identification

Brief Title: Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors

Official Title: Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction

Study ID: NCT01151670

Conditions

Brain Neoplasms, Malignant

Brain Neoplasms, Benign

Malignant Meningioma

Glioblastoma Multiforme

Anaplastic Astrocytoma

Interventions

pioglitazone

Pioglitazone

Study Description

Brief Summary: 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.

Detailed Description: 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.