27
Participants
Start Date
December 7, 2016
Primary Completion Date
June 15, 2020
Study Completion Date
June 15, 2020
5-day TMZ
Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
21-day TMZ
Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A
500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster
At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning
All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B
500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
The Preston Robert Tisch Brain Tumor Center at Duke, Durham
Collaborators (1)
Annias Immunotherapeutics, Inc.
OTHER
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Eric Thompson, M.D.
OTHER