PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 29, 2018

Primary Completion Date

April 27, 2023

Study Completion Date

April 30, 2026

Conditions
Recurrent MedulloblastomaRecurrent Brain Tumor, ChildhoodMalignant Glioma
Interventions
DRUG

PEP-CMV

Patients receive temozolomide (TMZ) 200 mg/m2/day x 5 days. On day 20, patients will receive a Tetanus-diphtheria pre-conditioning vaccination with Td (tetanus, diphtheria toxoid, adsorbed). Immunotherapy begins the following day, on day 21, with injection of the PEP-CMV vaccine as follows: PEP-CMV Component A mixed with Montanide ISA-51 intradermally administered half in the RIGHT groin and half in the LEFT groin.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors
All Listed Sponsors
collaborator

Pediatric Brain Tumor Foundation

UNKNOWN

collaborator

Annias Immunotherapeutics, Inc.

OTHER

lead

Daniel Landi

OTHER