Malignant Glioma
Conditions
Keywords
EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy
Brief summary
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.
Interventions
DRUGCDX-110 with GM-CSF
Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
DRUGTemozolomide
Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
Sponsors
Celldex Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival status | 5.5mo |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability characterized by physical examinations. | 2 years |
| Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes). | 2 years |
| Safety and tolerability characterized by urinalysis. | 2 years |
| Safety and tolerability characterized by vital signs. | 2 years |
| Safety and tolerability characterized by adverse events (term, grade, frequency). | 2 years |
| Immune response; antibody response to vaccine. | 2 years |
| Immune response; HLA typing. | 2 years |
| Overall survival. | indeterminate |
| Immune response; T-cell response to vaccine. | 2 years |
Countries
United States
Outcome results
None listed