22
Participants
Start Date
May 15, 2013
Primary Completion Date
January 1, 2019
Study Completion Date
February 1, 2020
Bevacizumab
"Treatment will be administered on an outpatient basis. Bevacizumab is administered by IV infusion at a dose of 10 mg/kg every 2 weeks for 24 weeks (induction therapy, see Schema). One cycle lasts 28 days and includes two infusions of bevacizumab. Clinical response will be assessed by audiology and MRI at weeks 12 and 24. Subjects with hearing decline at weeks 12 and 24 will be taken off of protocol. After week 24, patients with a clinical response or stable disease (together comprising clinical benefit) will transition to maintenance therapy with bevacizumab.~During the maintenance phase, subjects will be treated with open-label bevacizumab 5 mg/kg every 3 weeks for up to 72 weeks. Subjects will be followed with audiology and MRI scans every 12 weeks. The total time of the study will be 96 weeks (24 weeks induction + 72 weeks maintenance)."
New York University Medical Center, New York
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
National Cancer Institute (NCI), Bethesda
Children's HealthCare of Atlanta, Atlanta
Indiana Unversity, Indianapolis
University of Chicago, Chicago
Washington University - St. Louis, St Louis
University of Utah, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
Children' Hospital Boston and Massachusetts General Hospital, Boston
Cincinnati Children's Hospital Medical Center, Cincinnati
Collaborators (1)
Genentech, Inc.
INDUSTRY
University of Alabama at Birmingham
OTHER