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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00924820 |
Purpose
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:
Further describe the efficacy of this intervention as measured by
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplastic Meningitis |
Drug: Bevacizumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM) |
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bevacizumab |
Drug: Bevacizumab
10 mg/kg by vein over about 1 hour, every 2 weeks.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Morris D. Groves, MD, JD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00924820 History of Changes |
| Other Study ID Numbers: | 2009-0122 |
| Study First Received: | June 18, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Neoplastic Meningitis NM Advanced Cancers Brain Cancer Advanced Cancer Brain Diseases Central Nervous System Disorders CNS |
Bevacizumab Avastin Anti-VEGF monoclonal antibody rhuMAb-VEGF Spinal Cord meninges cerebrospinal fluid CSF |
|
Meningitis Meningeal Carcinomatosis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Antibodies |
Antibodies, Monoclonal Bevacizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses |