CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Bevacizumabdrug
Likely dose
Bevacizumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00924820
NCT00924820Phase 2Completed

A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)

M.D. Anderson Cancer Center·interventional·Posted Jun 19, 2009·Updated Dec 31, 2020

In Brief

A Phase 2 clinical trial evaluating Bevacizumab for Neoplastic Meningitis. Completed, enrolled 20 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.0 years ago

Interventions

Bevacizumabdrug

10 mg/kg by vein over about 1 hour, every 2 weeks.