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A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Malignant Glioma

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Trial Information

A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

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 GliadelĀ® Wafers.

- Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a
history of anaphylactic reactions to shellfish proteins.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival status

Outcome Time Frame:


Safety Issue:


Principal Investigator

Thomas Davis, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celldex Therapeutics


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

December 2013

Related Keywords:

  • Malignant Glioma
  • EGFRvIII vaccine temozolomide cancer vaccine immunotherapy
  • Glioblastoma
  • Glioma



Celldex Investigational Site Orange, California  92868
Celldex Investigational Site New Haven, Connecticut  06510
Celldex Investigational Site Gainesville, Florida  32610-0277
Celldex Investigational Site Chicago, Illinois  60611
Celldex Investigational Site Boston, Massachusetts  02115
Celldex Investigational Site Lansing, Michigan  48912
Celldex Investigational Site Hackensack, New Jersey  07601
Celldex Investigational Site Amherst, New York  14226
Celldex Investigational Site Durham, North Carolina  27710
Celldex Investigational Site Cincinnati, Ohio  45219
Celldex Investigational Site Philadelphia, Pennsylvania  19104
Celldex Investigational Site Houston, Texas  77030
Celldex Investigational Site Salt Lake City, Utah  84112
Celldex Investigational Site Charlottesville, Virginia  22908
Celldex Investigational Site Seattle, Washington  98195