Actively Recruiting
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
Led by Nationwide Children's Hospital · Updated on 2026-05-11
120
Participants Needed
13
Research Sites
308 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD
CONDITIONS
Official Title
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to 39 years at study enrollment
- Diagnosis of recurrent, progressive, or refractory medulloblastoma with measurable disease on MRI for stratum I
- Diagnosis of newly diagnosed high-grade glioma or DIPG for strata II and III
- Patients with metastatic disease are eligible
- Karnofsky score 60 50% for patients over 16 years or Lansky score 60 50 for patients 16 years or younger
- Prior therapy requirements including radiotherapy and chemotherapy as specified for each stratum
- Adequate bone marrow, renal, liver, and neurological function as detailed
- Patients of childbearing or child-fathering potential must agree to use medically acceptable birth control
- Signed informed consent obtained prior to enrollment
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unwilling to use effective contraception during and for 3 months after treatment
- Active infection requiring treatment
- Known HIV, HBV, or HCV infection; history of immunosuppressive disease
- Active renal, cardiac, or moderate to severe pulmonary disease requiring medical intervention
- Receiving concomitant immunosuppressive agents or tumor-directed therapies
- Receiving other investigational drug treatments
- Taking dexamethasone doses higher than 0.1 mg/kg/day up to 4 mg/day or equivalent
- Any clinically significant unrelated systemic illness
- Unable to return for required follow-up visits or studies
- High risk for imminent neurologic decline due to extensive tumor burden or brain shifts on MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
6
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
9
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
13
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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