Nervous System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Brain Diseases

Central Nervous System Diseases

Brain Neoplasms

Meningeal Carcinomatosis

Meningitis

Neuroinflammatory Diseases

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Bevacizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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.

Ivo D. Tremont, MD

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

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.

A Pilot Study of Bevacizumab for Neoplastic Meningitis

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

Neoplastic meningitis is considered an unmeasurable metastatic site by Response Evaluation Criteria in Solid Tumors (RECIST), and as such no standardized methodologies are routinely used; therefore response assessed from cerebrospinal fluid (CSF) obtained via lumbar puncture (and from ventricular reservoir if present) and analyzed for malignant cells along with reference recording of magnetic resonance imaging (MRI) of areas of enhancement over time; however, MRI alone in LMD/NM is considered non-evaluable by RECIST criteria. Those participants with only MRI criteria for enrollment, but who later develop CSF positivity after enrollment were declared "progressors" based on the CSF criteria.

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, e.g. participants with continued positive CSF cytology or flow cytometry.

Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening 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.

Genentech, Inc.

M.D. Anderson Cancer Center

Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

John F de Groot, Professor, Neuro-Oncology

Of the 20 registered, 5 were screening failures therefore are not included in the analysis.

Spots Global Cancer Trial Database for nm

Every month we try and update this database with for nm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nm

Every month we try and update this database with for nm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.