Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma
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.
Timeline
- Start
- 2011-08
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 2 mg/kg | Other |
| Subject | Bevacizumab | Monoclonal antibody | 4 mg/kg | Other |
| Subject | Bevacizumab | Monoclonal antibody | 6 mg/kg | Other |
| Subject | Bevacizumab | Monoclonal antibody | 8 mg/kg | Other |
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Other |