Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT01151670|
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms, Malignant Brain Neoplasms, Benign Malignant Meningioma Glioblastoma Multiforme Anaplastic Astrocytoma||Drug: pioglitazone Drug: Pioglitazone||Phase 1|
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.
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 (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Arm I
Pioglitazone 22.5 mg once daily by mouth
Pioglitazone 22.5 mg daily before, during and after radiation therapy.
Other Name: Actos
Experimental: Arm 2
Pioglitazone 45 mg once daily by mouth
Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
Other Name: Actos
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151670
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Michael Chan||Wake Forest University Health Sciences|