A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas
Background
- In vivo experiments have documented the ability of anti-vascular endothelial growth
factor (VEGF) antibodies like bevacizumab to inhibit tumor growth in various
preclinical tumor models, including gliomas.
- Given the pronounced neovasculature associated with over-expression of VEGF in
malignant gliomas, and abundant published data demonstrating the dependence of glioma
growth on the maintenance and proliferation of this neovasculature, bevacizumab
represents a potentially promising new therapeutic approach to these otherwise
refractory tumors.
Objective
- To establish data regarding the anti-tumor activity of bevacizumab in patients with
recurrent high-grade gliomas as determined by progression-free-survival.
- To obtain information regarding the safety of bevacizumab administered to patients with
recurrent high-grade gliomas.
Eligibility
- Adult patients with histologically proven intracranial malignant glioma
- Patients must have evidence for tumor progression by magnetic resonance imaging (MRI)
scan
- Patients must have progressed after radiation therapy and must have an interval of
greater than or equal to 4 weeks from the completion of radiation therapy to study
entry
Design
- Patients will be treated with bevacizumab by intravenous injection at a dose of 10mg/kg
every two weeks on a 4-week cycle.
- Prior to the first dose of bevacizumab and at the completion of the first 4-weeks of
treatment, patients will undergo a fludeoxyglucose 18F -positron emission tomography
(FDG-PET) scan (in cycle one only and then as needed) and a MRI perfusion scan.
- Peripheral blood circulating endothelial progenitor cells will be collected at the time
of each MRI-perfusion scan. Additionally, patients will undergo a MRI perfusion scan
within 48-96 hours of their first dose of bevacizumab (in cycle one only).
- For patients who are clinically/neurologically stable and with stable or responding
radiographic disease at the end of each treatment cycle, treatment will continue with
bevacizumab every 2 weeks, repeating MRI-perfusion scans at the conclusion (e.g. prior
to another administration of bevacizumab) of each 4 week cycle.
A total of 88 patients will be enrolled on this study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Progression Free Survival at 6 Months.
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
6 months
No
Teri Kreisl, M.D.
Principal Investigator
National Cancer Institute, National Institutes of Health
United States: Federal Government
060064
NCT00271609
December 2005
May 2014
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |