Clinical Trial: Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
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 Summary:
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.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Best tolerated dose of 2 different doses of orally administered pioglitazone [ Time Frame: From first dose to 1 day after last dose of drug ]
Original Primary Outcome: Safety, tolerability, and toxicity of 2 different doses of orally administered pioglitazone
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Wake Forest University Health Sciences
Dates:
Date Received: June 25, 2010
Date Started: August 2010
Date Completion:
Last Updated: May 25, 2017
Last Verified: July 2015