Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens

PHASE1TerminatedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 7, 2016

Primary Completion Date

June 15, 2020

Study Completion Date

June 15, 2020

Conditions
GlioblastomaGlioblastoma Multiforme
Interventions
DRUG

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

DRUG

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)

BIOLOGICAL

PEP-CMV: Component A

500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered

DRUG

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)

DRUG

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

BIOLOGICAL

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

Trial Locations (1)

27710

The Preston Robert Tisch Brain Tumor Center at Duke, Durham

Sponsors
All Listed Sponsors
collaborator

Annias Immunotherapeutics, Inc.

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Eric Thompson, M.D.

OTHER

NCT02864368 - Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens | Biotech Hunter | Biotech Hunter