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

Completed · Phase 2

Conditions studied: Malignant Glioma

In brief

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.

Key facts

Study ID

NCT00458601

Run by

Celldex Therapeutics

People needed

82

Starts

2007-08-01

Expected to finish

2016-05-01

Last updated by the study team

2018-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Celldex Investigational Site — Orange, California, United States
• Celldex Investigational Site — San Francisco, California, United States
• Celldex Investigational Site — San Francisco, California, United States
• Celldex Investigational Site — Stanford, California, United States
• Celldex Investigational Site — Stanford, California, United States
• Celldex Investigational Site — New Haven, Connecticut, United States
• Celldex Investigational Site — New Haven, Connecticut, United States
• Celldex Investigational Site — New Haven, Connecticut, United States
• Celldex Investigational Site — Gainesville, Florida, United States
• Celldex Investigational Site — Chicago, Illinois, United States
• Celldex Investigational Site — Evanston, Illinois, United States
• Celldex Investigational Site — Boston, Massachusetts, United States
• Celldex Investigational Site — Lansing, Michigan, United States
• Celldex Investigational Site — Saginaw, Michigan, United States
• Celldex Investigational Site — Saginaw, Michigan, United States
• Celldex Investigational Site — Hackensack, New Jersey, United States
• Celldex Investigational Site — Amherst, New York, United States
• Celldex Investigational Site — New York, New York, United States
• Celldex Investigational Site — New York, New York, United States
• Celldex Investigational Site — Durham, North Carolina, United States
• Celldex Investigational Site — Cincinnati, Ohio, United States
• Celldex Investigational Site — Cincinnati, Ohio, United States
• Celldex Investigational Site — Cincinnati, Ohio, United States
• Celldex Investigational Site — Cleveland, Ohio, United States
• Celldex Investigational Site — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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