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