Clinical Trial: A Pilot Study of Bevacizumab for Neoplastic Meningitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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 physi
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome:

    • Cerebrospinal fluid (CSF) Response Rate [ Time Frame: 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 ]
      CSF response as measured by total clearance of malignant cells from the CSF at 2, 4, 6, 12, 18, and 24 weeks, then every 8 weeks until up to week 54.
    • Time to Neurological Progression (TTNP) [ Time Frame: 6 weeks ]
      Time to neurological progression (TTNP) defined as worsening entry 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.


    Original Primary Outcome: Response Rate [ Time Frame: 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 ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: June 18, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: November 17, 2015
    Last Verified: September 2015