Clinical trial NCT00458601: Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
Official title: A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Glioma
Keywords: EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-04-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
* Gross total resection followed by conventional chemoradiation therapy without progression of disease.

Exclusion Criteria:

* Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
* Systemic corticosteroid therapy \> 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
* Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
* Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

Primary outcomes:
measure: Progression-free survival status
timeFrame: 5.5mo
Secondary outcomes:
measure: Safety and tolerability characterized by adverse events (term, grade, frequency).
timeFrame: 2 years
measure: Safety and tolerability characterized by physical examinations.
timeFrame: 2 years
measure: Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
timeFrame: 2 years
measure: Safety and tolerability characterized by urinalysis.
timeFrame: 2 years
measure: Safety and tolerability characterized by vital signs.
timeFrame: 2 years
measure: Immune response; T-cell response to vaccine.
timeFrame: 2 years
measure: Immune response; antibody response to vaccine.
timeFrame: 2 years
measure: Immune response; HLA typing.
timeFrame: 2 years
measure: Overall survival.
timeFrame: indeterminate
Other outcomes:
Locations:
city: Orange
country: United States
facility: Celldex Investigational Site
state: California
city: San Francisco
country: United States
facility: Celldex Investigational Site
state: California
city: San Francisco
country: United States
facility: Celldex Investigational Site
state: California
city: Stanford
country: United States
facility: Celldex Investigational Site
state: California
city: Stanford
country: United States
facility: Celldex Investigational Site
state: California
city: New Haven
country: United States
facility: Celldex Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Celldex Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Celldex Investigational Site
state: Connecticut
city: Gainesville
country: United States
facility: Celldex Investigational Site
state: Florida
city: Chicago
country: United States
facility: Celldex Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Celldex Investigational Site
state: Illinois
city: Boston
country: United States
facility: Celldex Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: Celldex Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: Celldex Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: Celldex Investigational Site
state: Michigan
city: Hackensack
country: United States
facility: Celldex Investigational Site
state: New Jersey
city: Amherst
country: United States
facility: Celldex Investigational Site
state: New York
city: New York
country: United States
facility: Celldex Investigational Site
state: New York
city: New York
country: United States
facility: Celldex Investigational Site
state: New York
city: Durham
country: United States
facility: Celldex Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Orange Village
country: United States
facility: Celldex Investigational Site
state: Ohio
city: West Chester
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Celldex Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Celldex Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Celldex Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Celldex Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Celldex Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Celldex Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Celldex Investigational Site
state: Washington
Study officials:
References:
citation: Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro Oncol. 2015 Jun;17(6):854-61. doi: 10.1093/neuonc/nou348. Epub 2015 Jan 13.