A Pilot Study of Bevacizumab for Neoplastic Meningitis
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may
affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of
this drug will also be studied.
Objectives:
1. Primary:
1. Determine preliminary response data of intravenous bevacizumab in patients with NM
a. As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6,
12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and
b. Time to neurological progression (TTNP)
2. Secondary:
1. Evaluate the safety of intravenous bevacizumab in patients with NM
2. Further describe the efficacy of this intervention as measured by
1. improvement of MR imaging evidence of disease
2. overall survival
3. maintenance of quality of life
3. Determine effects of systemically administered bevacizumab on CSF, serum, and urine
Vascular endothelial growth factor (VEGF)levels levels
4. Correlate changes in CSF VEGF with response measurements.
5. Correlate primary tumor tissue VEGF expression with CSF VEGF levels
6. Correlate urine VEGF levels with serum and CSF VEGF levels
7. Evaluate serum and CSF VEGF index