A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
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
Yes
Ivo D. Tremont, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0122
NCT00924820
June 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |