Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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)|
- 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. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- To describe changes of quantitative blood brain barrier permeability measurements (Ktrans) of a standard gadolinium (Gd) MRI contrast between bevacizumab anti-angiogenic therapy and dexamethasone. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- To describe relative cerebral blood volume (rCBV) changes obtained using ferumoxytol an iron oxide nanoparticle blood pool agent. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- To assess vascular dynamic parameters (rCBV and Ktrans) values at progression. [ Time Frame: at progression ] [ Designated as safety issue: No ]
- To describe the changes of the vascular dynamic parameters (rCBV, Ktrans) with the changes of standard gadolinium enhancing tumor volume [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- To describe post contrast tumor volume (enhancement) of gadolinium and ferumoxytol. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Group 1
Both groups will receive an intravenous chemotherapeutic drug (carboplatin). The first study group (n=6) will receive bevacizumab, the antiangiogenic agent for three weeks, then dexamethasone for three weeks.
Other Name: AMAG Pharmaceuticals, Inc., Code 7228
Active Comparator: Group 2
Both groups will receive an intravenous chemotherapeutic drug (carboplatin). The second study group (n=6) will receive dexamethasone for 3 weeks, then switch to bevacizumab, the antiangiogenic agent, for 3 weeks.
Other Name: AMAG Pharmaceuticals, Inc., Code 7228
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769093
|Contact: Edward A Neuwelt, MDfirstname.lastname@example.org|
|Contact: Cynthia A Lacy, BSNemail@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator: Edward A Neuwelt, MD|
|Principal Investigator:||Edward A Neuwelt, MD||Oregon Health and Science University|