- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151670
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family
- Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes
- Patients who take insulin
- Patients who have NYHA class III or IV heart failure
- Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit)
- Patients who have significantly impaired renal function (creatinine >= 1.5)
- Patients who are significantly anemic (hematocrit < 33% in men, or < 30% in women)
- Patients who have symptomatic edema (>= grade 2)
- Patients who are on medications that have been shown to have a drug interaction with pioglitazone: atorvastatin (doses > 80 mg/day), systemic anti-fungals, medications with significant CYP 3A4 inhibiting properties
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study if their pregnancy precludes radiation treatment because ionizing radiation used in radiation treatment is an agent with known potential for teratogenic or abortifacient effects
- Patients with psychiatric or social illnesses that may impair compliance with the trial requirements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Pioglitazone 22.5 mg once daily by mouth
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Pioglitazone 22.5 mg daily before, during and after radiation therapy.
Other Names:
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Experimental: Arm 2
Pioglitazone 45 mg once daily by mouth
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Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best tolerated dose of 2 different doses of orally administered pioglitazone
Time Frame: From first dose to 1 day after last dose of drug
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From first dose to 1 day after last dose of drug
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicities associated with both dose levels
Time Frame: From first dose to 1 day after last dose of drug
|
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
|
From first dose to 1 day after last dose of drug
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Chan, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neurocognitive Disorders
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Cognition Disorders
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Neoplasms
- Glioblastoma
- Cognitive Dysfunction
- Brain Neoplasms
- Astrocytoma
- Meningioma
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Pioglitazone
Other Study ID Numbers
- IRB00014528
- NCI-2009-01452 (Registry Identifier: CTRP)
- CCCWFU 97409 (Other Identifier: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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