Bevacizumab to Treat Recurrent Brain Tumors
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas
Background:
Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels
in tumors. Inhibiting the formation of these blood vessels may slow or stop disease
progression by diminishing the supply of life-sustaining nutrients and oxygen the blood
delivers to the tumor.
Bevacizumab is approved for treating colorectal cancer and has shown activity against brain
tumor cells in laboratory and animal tests.
Objectives:
To examine the safety and side effects of bevacizumab in patients with recurrent brain
tumors.
To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.
Eligibility:
Patients 18 years of age and older with a brain tumor that continues to grow after receiving
standard treatments.
Design:
Patients complete the following procedures during the study:
- Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.
- PET scan before the first dose of bevacizumab, at the end of the first treatment cycle,
and as needed after that.
- MRI scan before the first dose of bevacizumab, within 48-96 hours after the first dose
of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood
for research is collected at the time of each MRI scan to look at specific cells.
- Physical and neurological examinations every 2 weeks for the first treatment cycle and
then every 4 weeks.
- Quality-of-life questionnaires every 4 weeks.
Background
- In vivo experiments have documented the ability of anti-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 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 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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