Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 15, 2013

Primary Completion Date

January 1, 2019

Study Completion Date

February 1, 2020

Conditions
Neurofibromatosis Type 2Progressive Vestibular Schwannomas
Interventions
DRUG

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)."

Trial Locations (12)

10016

New York University Medical Center, New York

19096

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20892

National Cancer Institute (NCI), Bethesda

30324

Children's HealthCare of Atlanta, Atlanta

46202

Indiana Unversity, Indianapolis

60637

University of Chicago, Chicago

63110

Washington University - St. Louis, St Louis

84132

University of Utah, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

02115

Children' Hospital Boston and Massachusetts General Hospital, Boston

45229-4006

Cincinnati Children's Hospital Medical Center, Cincinnati

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of Alabama at Birmingham

OTHER

NCT01767792 - Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas | Biotech Hunter | Biotech Hunter