Education and Training
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: CDX-110 with GM-CSF
- drug: Temozolomide
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting