PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

June 15, 2028

Study Completion Date

June 15, 2030

Conditions
High Grade GliomaDiffuse Intrinsic Pontine GliomaRecurrent Medulloblastoma
Interventions
BIOLOGICAL

PEP-CMV

The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.

DRUG

Temozolomide

Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1

BIOLOGICAL

Tetanus Diphtheria Vaccine

Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.

Trial Locations (12)

19104

NOT_YET_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20010

RECRUITING

Children's National Medical Center, Washington D.C.

27710

RECRUITING

Duke Cancer Center, Durham

33155

RECRUITING

Nicklaus Children's Hospital, Miami

43205

RECRUITING

Nationwide Children's Hospital, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

60611

NOT_YET_RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

RECRUITING

St. Louis Children's Hospital, St Louis

77030

RECRUITING

Texas Children's Hospital, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

98105

RECRUITING

Seattle Children's Hospital, Seattle

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
lead

Nationwide Children's Hospital

OTHER