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Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01151670
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE June 25, 2010
First Posted Date  ICMJE June 28, 2010
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE August 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
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 Measures  ICMJE
 (submitted: June 25, 2010)
Safety, tolerability, and toxicity of 2 different doses of orally administered pioglitazone
Change History Complete list of historical versions of study NCT01151670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
  • 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 Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Brain Neoplasms, Malignant
  • Brain Neoplasms, Benign
  • Malignant Meningioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
Intervention  ICMJE
  • Drug: pioglitazone
    Pioglitazone 22.5 mg daily before, during and after radiation therapy.
    Other Name: Actos
  • Drug: Pioglitazone
    Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
    Other Name: Actos
Study Arms  ICMJE
  • Experimental: Arm I
    Pioglitazone 22.5 mg once daily by mouth
    Intervention: Drug: pioglitazone
  • Experimental: Arm 2
    Pioglitazone 45 mg once daily by mouth
    Intervention: Drug: Pioglitazone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2010)
100
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01151670
Other Study ID Numbers  ICMJE IRB00014528
NCI-2009-01452 ( Registry Identifier: CTRP )
CCCWFU 97409 ( Other Identifier: Wake Forest University Health Sciences )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Chan Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP