A Pilot Study of Bevacizumab for Neoplastic Meningitis
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.
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)
- Evaluate the safety of intravenous bevacizumab in patients with NM
Further describe the efficacy of this intervention as measured by
- improvement of MR imaging evidence of disease
- overall survival
- maintenance of quality of life
- Determine effects of systemically administered bevacizumab on CSF, serum, and urine Vascular endothelial growth factor (VEGF)levels levels
- Correlate changes in CSF VEGF with response measurements.
- Correlate primary tumor tissue VEGF expression with CSF VEGF levels
- Correlate urine VEGF levels with serum and CSF VEGF levels
- Evaluate serum and CSF VEGF index
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)|
- Cerebrospinal fluid (CSF) Response Rate [ Time Frame: 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 for 52 weeks ] [ Designated as safety issue: Yes ]CSF response as measured by total clearance of malignant cells from the CSF at 2, 4, 6, 12, 18, and 24 weeks, then every 8 weeks until up to week 54.
- Time to Neurological Progression (TTNP) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Time to neurological progression (TTNP) defined as worsening entry clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy.
|Study Start Date:||June 2009|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
10 mg/kg by vein over about 1 hour, every 2 weeks.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924820
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ivo D. Tremont, MD||M.D. Anderson Cancer Center|