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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Alabama at Birmingham
Study ID
NCT01767792
Phase
PHASE2
Status
Completed

Conditions

  • Neurofibromatosis Type 2
  • Progressive Vestibular Schwannomas

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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).

Study Details

To determine the hearing response rate at 24 weeks after treatment with bevacizumab for symptomatic vestibular schwannomas (VS) in children and young adults with Neurofibromatosis Type 2 (NF 2).

Key Dates

First listed
Jan 14, 2013
Start date
May 15, 2013
Status verified
Jan 2021
Primary completion
Jan 1, 2019
Completion
Feb 1, 2020

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Follow participant for 2 years and assess hearing response rates

Primary Outcome Measure

Improvement in Hearing [ Time Frame: 6 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's HealthCare of AtlantaAtlantaGeorgia30324-
University of ChicagoChicagoIllinois60637-
Indiana UnversityIndianapolisIndiana46202-
National Cancer Institute (NCI)BethesdaMaryland20892-
Children' Hospital Boston and Massachusetts General HospitalBostonMassachusetts02115-
Washington University - St. LouisSt LouisMissouri63110-
New York University Medical CenterNew YorkNew York10016-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-4006-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19096-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's National Medical Center· Washington D.C., DCChildren's HealthCare of Atlanta· Atlanta, GAUniversity of Chicago· Chicago, ILIndiana Unversity· Indianapolis, INNational Cancer Institute (NCI)· Bethesda, MD

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