Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00769093
Study type Interventional
Source OHSU Knight Cancer Institute
Contact
Status Terminated
Phase Phase 1
Start date October 2008
Completion date July 2014

See also
  Status Clinical Trial Phase
Completed NCT02810899 - Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy Phase 4
Withdrawn NCT00977795 - A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors Phase 1/Phase 2
Recruiting NCT00787982 - Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors Phase 1/Phase 2
Withdrawn NCT00555984 - Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors N/A
Completed NCT00038441 - Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas Phase 1/Phase 2
Recruiting NCT03619694 - Role of MR Spectroscopy in Brain Tumors
Withdrawn NCT01236586 - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia Phase 1
Unknown status NCT02775136 - An Evaluation of a Non-invasive Brain Monitor N/A
Completed NCT01244737 - FLT-PET Imaging of Brain Tumors in Children Phase 2
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00392119 - MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors Phase 1
Terminated NCT00038389 - Study of Vioxx and Radiation Therapy for Brainstem Glioma Phase 1
Completed NCT00062478 - Study of Karenitecin (BNP1350) in Patients With Brain Tumors Phase 2
Recruiting NCT05049148 - Platelets Activation in Brain Neoplasms N/A
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Recruiting NCT04712721 - Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins. Early Phase 1
Completed NCT02881957 - Hypovitaminosis D in Neurocritical Patients Phase 2/Phase 3
Terminated NCT01954576 - NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme N/A
Recruiting NCT05538130 - A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors Phase 1
Recruiting NCT04111588 - Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases