Status:
COMPLETED
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
Lead Sponsor:
Celldex Therapeutics
Conditions:
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 disea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00458601
Start Date
August 1 2007
End Date
May 1 2016
Last Update
January 16 2018
Active Locations (34)
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1
Celldex Investigational Site
Orange, California, United States, 92868
2
Celldex Investigational Site
San Francisco, California, United States, 94143-0622
3
Celldex Investigational Site
San Francisco, California, United States, 94143
4
Celldex Investigational Site
Stanford, California, United States, 94305-5826