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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Pioglitazone 22.5 mg daily before, during and after radiation therapy.
Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Best tolerated dose of 2 different doses of orally administered pioglitazone
Time frame: From first dose to 1 day after last dose of drug
Toxicities associated with both dose levels
Time frame: From first dose to 1 day after last dose of drug
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.
Time frame: From first dose to 1 day after last dose of drug
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