A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

April 30, 2015

Study Completion Date

May 17, 2016

Conditions
GlioblastomaSmall Cell GlioblastomaGiant Cell GlioblastomaGliosarcomaGlioblastoma With Oligodendroglial ComponentRecurrent GlioblastomaRelapsed Glioblastoma
Interventions
DRUG

Bevacizumab

A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.

DRUG

Rindopepimut (CDX-110) with GM-CSF

Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.

DRUG

KLH

KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.

Trial Locations (45)

11725

The Long Island Brain Tumor Center at Neurology Surgery, P.C., Commack

14226

Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch, Amherst

14642

University of Rochester Medical Center, Rochester

15232

University of Pittsburgh Cancer Institute, Pittsburgh

18103

Lehigh Valley Hospital-John and Dorothy Morgan Cancer Center, Allentown

19104

University of Pennsylvania, Philadelphia

21287

The Johns Hopkins Hospital, Baltimore

27157

Wake Forest Baptist Health, Winston-Salem

27710

The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center, Durham

30309

Piedmont Atlanta Hospital, Atlanta

30342

Atlanta Cancer Care, Atlanta

32806

Orlando Health, Inc., Orlando

33021

Memorial Cancer Institute, Hollywood

33606

Tampa General Hospital, Tampa

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt-Ingram Cancer Center, Nashville

44106

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

45267

University of Cincinnati Cancer Institute, Cincinnati

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48912

Sparrow Cancer Center, Lansing

55407

John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR, Minneapolis

60201

NorthShore University Health System, Evanston

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

75246

Baylor Research Institute, Dallas

77030

UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800, Houston

78705

Texas Oncology Midtown, Austin

80045

University of Colorado, Denver, Aurora

84116

Utah Cancer Specialists, Salt Lake City

85013

St. Joseph's Hospital and Medical Center / Barrow Neurological Institute, Phoenix

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90089

University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles

92868

UC Irvine Chao Family Comprehensive Cancer Center, Orange

94143

University of California San Francisco, San Francisco

94305

Stanford Cancer Institute, Stanford University, Stanford

97232

Legacy Research Institute, Portland

98122

Swedish Neuroscience Research, Seattle

98195

University of Washington Medical Center, Seattle

60637-1470

University of Chicago, Chicago

02115

Dana-Farber Cancer Institute and Mass General Hospital, Boston

08818

New Jersey Neuroscience Institute JFK Medical Center, Edison

07601

Hackensack University Medical Center, Hackensack

11794-8121

Stony Brook University Hospital, Stony Brook

02903

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
lead

Celldex Therapeutics

INDUSTRY

NCT01498328 - A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma | Biotech Hunter | Biotech Hunter