Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma
NCT01083966 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-04-09
Summary
A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or brain-stem compression from growing VS. Because of the promising results in preliminary studies of Bevacizumab and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe treatment for patients with VS. Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS.
Conditions
- Vestibular Schwannoma
Interventions
- DRUG
-
Bevacizumab (Avastin)
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab in Vestibular Schwannoma This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS
Sponsors & Collaborators
-
Feinstein Institute for Medical Research
collaborator OTHER -
Hofstra North Shore
collaborator OTHER -
Northwell Health
lead OTHER
Principal Investigators
-
John Boockvar, MD · Feinstein Institute for Medical Research
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2026-01-31
- Completion
- 2027-01-31
Countries
- United States
Study Locations
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