Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

November 30, 2010

Study Completion Date

May 31, 2016

Conditions
Malignant Glioma
Interventions
DRUG

CDX-110 with GM-CSF

Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.

DRUG

Temozolomide

Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.

Trial Locations (34)

10032

Celldex Investigational Site, New York

10065

Celldex Investigational Site, New York

14226

Celldex Investigational Site, Amherst

19104

Celldex Investigational Site, Philadelphia

22908

Celldex Investigational Site, Charlottesville

27710

Celldex Investigational Site, Durham

44106

Celldex Investigational Site, Cleveland

44122

Celldex Investigational Site, Orange

44145

Celldex Investigational Site, Westlake

44195

Celldex Investigational Site, Cleveland

45219

Celldex Investigational Site, Cincinnati

48601

Celldex Investigational Site, Saginaw

48604

Celldex Investigational Site, Saginaw

48912

Celldex Investigational Site, Lansing

60201

Celldex Investigational Site, Evanston

60611

Celldex Investigational Site, Chicago

77030

Celldex Investigational Site, Houston

78229

Celldex Investigational Site, San Antonio

84112

Celldex Investigational Site, Salt Lake City

92868

Celldex Investigational Site, Orange

94143

Celldex Investigational Site, San Francisco

94305

Celldex Investigational Site, Stanford

98195

Celldex Investigational Site, Seattle

94143-0622

Celldex Investigational Site, San Francisco

94305-5826

Celldex Investigational Site, Stanford

06510

Celldex Investigational Site, New Haven

06519

Celldex Investigational Site, New Haven

06520

Celldex Investigational Site, New Haven

32610-0277

Celldex Investigational Site, Gainesville

02115

Celldex Investigational Site, Boston

07601

Celldex Investigational Site, Hackensack

45267-0502

Celldex Investigational Site, Cincinnati

45267-0769

Celldex Investigational Site, Cincinnati

45069-6542

Celldex Investigational Site, West Chester

Sponsors
All Listed Sponsors
lead

Celldex Therapeutics

INDUSTRY

NCT00458601 - Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme | Biotech Hunter | Biotech Hunter