Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Pati… (NCT01151670) | Clinical Trial Compass
CompletedPhase 1
Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
United States18 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed brain tumors of the following types: Group 1: malignant brain tumors (glioblastoma multiforme, anaplastic gliomas, brain metastases, and other malignant brain tumors); or Group 2: low grade brain tumors (low grade gliomas, meningiomas, and other low grade brain tumors)
* All stages and grades of brain tumors are eligible
* Patients must have an ECOG performance status of 0-2
* Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions)
* Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation
* Patients must have measurable disease and/or relevant anatomic features using Magnetic Resonance Imaging
* Prior therapies (cytotoxic, surgery, and radiation) are acceptable
* Use of steroids is acceptable when indicated
* Patients must be able to understand and willingly give informed written consent to participate
* Women of childbearing potential must not be pregnant or nursing and must use medically appropriate contraception if sexually active
* Patients must have a life expectancy of greater than 3 months
* Patients must be willing to comply with an oral treatment regimen and be able to swallow oral study tablets
Exclusion Criteria:
* Hist…
What they're measuring
1
Best tolerated dose of 2 different doses of orally administered pioglitazone
Timeframe: From first dose to 1 day after last dose of drug