Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2018 |
| Start Date: | August 2007 |
| End Date: | May 2016 |
A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed 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.
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.
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.
We found this trial at
25
sites
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