Trials / Completed
CompletedNCT01151670
Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Brain Neoplasms, Malignant
- Brain Neoplasms, Benign
- Malignant Meningioma
- Glioblastoma Multiforme
- Anaplastic Astrocytoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pioglitazone | Pioglitazone 22.5 mg daily before, during and after radiation therapy. |
| DRUG | Pioglitazone | Pioglitazone 45 mg by mouth daily before, during and after radiation therapy |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2010-06-28
- Last updated
- 2018-08-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01151670. Inclusion in this directory is not an endorsement.