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NCT00924820 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Bevacizumab for Neoplastic Meningitis
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00924820: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00924820 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924820, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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
Primary Outcome
CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response,
Interventions
- DRUG Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT00924820 record still lists
NCT00924820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Bevacizumab is the first listed.
NCT00924820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00924820 about?
NCT00924820 is a clinical study titled "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. Objectives: 1\. Primary: 1\. Determine preliminary response data of intravenous be...
What is the current status of trial NCT00924820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2009-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00924820?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT00924820?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00924820's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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