Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy

Stopped early · Phase 1

Conditions studied: Brain Neoplasms

In brief

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 resonance imaging (MRI) will be used to evaluate the difference between the 2 treatments. The usual contrast agent (gadolinium) and an iron containing contrast agent called "ferumoxytol" may help us to evaluate the differences between bevacizumab and dexamethasone effects on imaging of a brain tumor called high grade glioma. For this purpose, after intravenous contrast agent injection, special MR scans (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) will be performed to see the microvascular changes in the brain and tumor.

Key facts

Study ID

NCT00769093

Run by

OHSU Knight Cancer Institute

People needed

6

Starts

2008-10-01

Expected to finish

2014-07-01

Last updated by the study team

2017-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 Exclusion Criteria: History of hypertensive encephalopathy; New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF); History of myocardial infarction or unstable angina within 6 months prior to start of the study; History of stroke or transient ischemic attack within 6 months prior to study enrollment; Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to start of the study; Evidence of bleeding diathesis or coagulopathy; on therapeutic anti-coagulants.
• Subjects unable to undergo an MRI with contrast
• Ferumoxytol Exclusion Criteria: History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005). Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
• Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions).Patients with transferrin saturation greater than 60%
• Inability or unwillingness to undergo the complete series of imaging sessions. Inability or unwillingness to return to the neuro-oncology clinic at Oregon Health and Science University (OHSU) for the one month follow-up

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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