Pilot Study to Compare Dynamic MR Imaging Changes in Patients With Recurrent High Grade Glioma, Receiving an Antiangiogenic Drug, Bevacizumab, Versus Dexamethasone. Dual Agent MR Imaging Study, Using Gadolinium and Ferumoxytol (Code 7228)
Adult patients (>18 years old) with recurrent high grade glioma (confirmed by radiology and
tissue sample), who have progressed on prior temazolomide + radiation therapy, will be
recruited from the neurology, neurosurgery, or neuro-oncology clinics. Patients will be
enrolled if they meet the study inclusion and exclusion criteria
Patients will be scanned at four different time-points (4 MRI series) (1) before the
beginning of the treatment (base line), (2) Three weeks after the first treatment, (3) Three
weeks after the second treatment, and (4) at time of progression of the disease. Each MRI
time-point will consist of a series of MRI's on three consecutive days. On the first day,
gadolinium (0.1 mmol/kg) will be injected for the MRI scan. On the following day ferumoxytol
(2 mg/kg) and on the third day, the MRI scan will be done without additional contrast agent,
to see the delayed contrast enhancement of ferumoxytol.
Subjects will be on treatment including a chemotherapeutic agent called carboplatin combined
with either bevacizumab or dexamethasone; 6 patients will receive carboplatin-bevacizumab,
followed by carboplatin-dexamethasone, another 6 patients will receive carboplatin-
dexamethasone, followed by carboplatin-bevacizumab. After the 3rd time-point, all the
patients will continue on carboplatin-bevacizumab treatment (which is currently not an FDA
approved combination for brain tumors, however it is widely used throughout the
country).There will be monthly clinical visits with clinical MRI until progression of the
disease. There will be a follow up visit, 1 month after the last ferumoxytol injection.
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The primary objective of this project is to describe quantitative imaging changes of brain tumor vascularity after anti-angiogenic therapy versus steroid therapy. This objective will be accomplished with the following aims and associated hypotheses.
15 weeks
No
Edward A Neuwelt, MD
Principal Investigator
Oregon Health and Science University
United States: Food and Drug Administration
OHSU-3678
NCT00769093
October 2008
February 2014
Name | Location |
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Oregon Health & Science University | Portland, Oregon 97201 |