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

GOALS

To determine if there is improved hearing after 24 weeks of treatment with bevacizumab for symptomatic vestibular schwannomas (cranial nerve tumors) in children and young adults with NF2 who are six years and older.

DRUGS

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 reducing the size of the vestibular schwannomas and improving hearing.

ELIGIBILITY

Participants must have NF2, are 6 years and older, and have a vestibular schwannoma that cannot be removed surgically or would be at high risk for complications from surgery.

PROTOCOL

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

PROTOCOL CHAIRS

• Scott Plotkin, MD, PhD, Chair
• James Tonsgard, MD, Co-Chair
• Nicole Ullrich, MD, PhD, Co-Chair
• Elizabeth Schorry, MD, Co-Chair

CURRENT STATUS

This study is complete and closed. Please see trial results via publications or by visiting clinicaltrials.gov/ct2/show/results/NCT01767792