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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
N/A
Open (Enrolling)
Both
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:

Interventional

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:

5.5mo

Safety Issue:

No

Principal Investigator

Thomas Davis, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celldex Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

CDX110-003

NCT ID:

NCT00458601

Start Date:

August 2007

Completion Date:

December 2013

Related Keywords:

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

Name

Location

Celldex Investigational SiteOrange, California  92868
Celldex Investigational SiteNew Haven, Connecticut  06510
Celldex Investigational SiteGainesville, Florida  32610-0277
Celldex Investigational SiteChicago, Illinois  60611
Celldex Investigational SiteBoston, Massachusetts  02115
Celldex Investigational SiteLansing, Michigan  48912
Celldex Investigational SiteHackensack, New Jersey  07601
Celldex Investigational SiteAmherst, New York  14226
Celldex Investigational SiteDurham, North Carolina  27710
Celldex Investigational SiteCincinnati, Ohio  45219
Celldex Investigational SitePhiladelphia, Pennsylvania  19104
Celldex Investigational SiteHouston, Texas  77030
Celldex Investigational SiteSalt Lake City, Utah  84112
Celldex Investigational SiteCharlottesville, Virginia  22908
Celldex Investigational SiteSeattle, Washington  98195