Open-label, phase 2 study of bevacizumab (Avastin®) in children and young adults with neurofibromatosis 2 and progressive vestibular schwannomas that are poor candidates for standard treatment with surgery or radiation

Goal

To determine if there is improved hearing after 24 weeks of treatment with bevacizumab for symptomatic vestibular schwannomas (cranial nerve tumor) in children and young adults with NF2 ages 6+ years.

Drug

Bevacizumab is a VEGF inhibitor and has been identified as a possible therapy. The initial experience treating ten NF2 patients at risk for complete hearing loss with bevacizumab on a compassionate care basis showed promising results in reduction the size of the vestibular schwannomas and improved hearing.

Eligibility

This study is open to patients with NF2 between the ages of > 6 who have a vestibular schwannoma that is not able to be removed surgically or who would be at a high risk for complications from surgery. There must be documented hearing loss due to vestibular schwannoma and documented growth of the vestibular schwannoma in the past 18 months. Patients must have recovered from prior chemotherapy, radiation or surgery and have had no prior treatment with bevacizumab to be eligible for this study. A full list of criteria can be obtained by contacting one of the study sites and/or checking http://www.clinicaltrials.gov.

Protocol

Study participants receive bevacizumab administered by IV infusion every 2 weeks for first 24 weeks during the induction phase.   Clinical response is assessed by MRI and audiology at weeks 12 and 24. If there is clinical response or stable disease, then participant can transition to maintenance phase and will receive IV infusion every 3 weeks for up to 72 weeks. Response is evaluated every 3 months during maintenance phase.

Current Status

The NF2 Study is currently enrolling eligible participants. Up to 22 subjects will be enrolled in this clinical trial.