Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
Trial ID or NCT#
NCT00458601
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Lawrence Recht, MD
Neuro-oncologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
