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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 (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