Status:
TERMINATED
Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
AMAG Pharmaceuticals, Inc.
Conditions:
Brain Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to learn more about imaging changes induced by a new therapeutic agent, bevacizumab with the standard steroid, dexamethasone in patients with high grade glioma. Magnetic r...
Detailed Description
Adult patients (\>18 years old) with recurrent high grade glioma (confirmed by radiology and tissue sample), who have progressed on prior temozolomide + radiation therapy, will be recruited from the n...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Age equal or greater than 18 years
- Histologically confirmed high grade glioma
- Radiographic demonstration of disease progression following prior therapy of temozolomide + radiation
- Patient scheduled for bevacizumab + standard IV chemotherapy therapy
- Bi-dimensionally measurable disease on gadolinium enhanced T1 weighted MR scans
- An interval of at least 4 weeks since prior surgical resection
- Patients corticosteroid dose must be 4 mg per day or less.
- Karnofsky performance status greater than or equal to 50
- Life expectancy greater than 12 weeks
- Ability to comply with study and follow-up procedures
Exclusion
- Pregnant or nursing females
- 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
- Known liver function insufficiency, stage IV or V renal insufficiency
- Disease and Treatment History: Prior treatment with bevacizumab, or another vascular endothelial growth factor (VEGF) or VEGFR-targeted agent; Need for urgent palliative intervention for primary disease (e.g., impending herniation
- Bevacizumab
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00769093
Start Date
October 1 2008
End Date
July 1 2014
Last Update
April 21 2017
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239