Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

Study Overview
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Brief Summary
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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
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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 forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Official Title
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A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: Axitinib
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axitinib + Radiation Therapy<br>Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity | Drug: Axitinib<br>* 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity<br>* Other names: AG-013736;Radiation: Radiation Therapy<br>* 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy<br>* Other names: Hypofractionated radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | average 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBM, brain tumor