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Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
Not Recruiting
Trial ID: NCT00458601
Purpose
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.
Official Title
A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Stanford Investigator(s)
Lawrence Recht, MD
Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery
Eligibility
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.
Intervention(s):
drug: CDX-110 with GM-CSF
drug: Temozolomide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061