A Pilot Study of Bevacizumab for Neoplastic Meningitis

Conditions

• Neoplastic Meningitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Jun 19, 2009

Start date

Jun 30, 2009

Status verified

Dec 2020

Primary completion

Sep 30, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells [ Time Frame: 1 year (54 weeks) of treatment ]

Locations (1)

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