Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-13 @ 4:47 PM
Study NCT ID:
NCT00924820
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2009-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Bevacizumab for Neoplastic Meningitis
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The Study Drug:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour.
Study Visits:
At Weeks 2 and 4:
* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.
At Weeks 6, 12, 18, and 24, and then every 8 weeks:
* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will have a physical exam (Weeks .
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.
* You will complete the questionnaire about your quality of life.
* You will have an MRI scan to check the status of the disease.
* Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period.
Every 2 weeks, your blood pressure will be measured.
Length of Study:
You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
If you go off study early, the following tests and procedures will be performed:
* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
Follow-up Visits:
If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed:
* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
You will have an MRI scan to check the status of the disease.
-If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational.
Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour.
Study Visits:
At Weeks 2 and 4:
* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.
At Weeks 6, 12, 18, and 24, and then every 8 weeks:
* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will have a physical exam (Weeks .
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.
* You will complete the questionnaire about your quality of life.
* You will have an MRI scan to check the status of the disease.
* Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period.
Every 2 weeks, your blood pressure will be measured.
Length of Study:
You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
If you go off study early, the following tests and procedures will be performed:
* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
Follow-up Visits:
If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed:
* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
You will have an MRI scan to check the status of the disease.
-If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational.
Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-01610 | REGISTRY | NCI CTRP | View |