Clinical Trial Details
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NCT00769093 : Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy
PhasePhase 1
AgesMin: 18 Years Max: 75 Years
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
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