Completed

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

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What is being tested

Bevacizumab

Drug
Who is being recruted

Brain Diseases+7

+ Brain Neoplasms

+ Central Nervous System Diseases

Over 18 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleA Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
NCT00924820
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesMeningeal NeoplasmsNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsMeningeal Carcinomatosis

Criteria

11 inclusion criteria required to participate
History of breast cancer, lung cancer or melanoma
Diagnosis of NM as proven either by: 1. positive CSF cytology, or 2. magnetic resonance neuro-imaging, or 3. both
Age >/=18 years.
Routine laboratory studies adequate with bilirubin </= 1.5 x upper limit of normal (ULN), AST < 2.5 x ULN, creatinine <1.0 x ULN, granulocytes >1500, platelets> 75,000; Hb >/= 9.0.
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17 exclusion criteria prevent from participating
Evidence of active CNS hemorrhage in the brain or tumor lesions
Besides NM, other known CNS disease, except for treated brain metastases(Patients must be at least 1 month out from brain irradiation and have no evidence of progression or hemorrhage at that time, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician.
2. continued) With respect to irradiation for other purpose (for NM or bone metastases, etc) patients need only 1 week out from the completion of irradiation. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
Patients with clinically significant cardiovascular disease are excluded 1) Inadequately controlled HTN (SBP > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication). 2) Prior history of hypertensive crisis or hypertensive encephalopathy. 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Texas MD Anderson Cancer Center

Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps
CompletedOne Study Center