Status:
TERMINATED
Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Pfizer
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.
Detailed Description
The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from fo...
Eligibility Criteria
Inclusion
- Newly diagnosed patients with histologically proven glioblastoma multiforme
- Age above 70 years
- Karnofsky score of 50-80
- Adequate organ function as defined by laboratory values
- Life expectancy of \>12 weeks
- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
Exclusion
- Prior treatment with chemotherapy or radiation for glioblastoma multiforme
- Patients with extensive tumor hemorrhage
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01508117
Start Date
August 1 2011
End Date
October 1 2012
Last Update
September 19 2017
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502