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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: AMAG Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Angiogenesis Inhibitors; BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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