Actively Recruiting
Phase 2 Trial of PEP-CMV Vaccine Targeting CMV Antigen for Pediatric High-grade Glioma, Diffuse Intrinsic Pontine Glioma, and Recurrent Medulloblastoma
Led by Nationwide Children's Hospital · Updated on 2026-05-11
120
Participants Needed
13
Research Sites
104 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
Researchers are evaluating a new immunotherapy approach using the PEP-CMV vaccine in children and young adults aged 3 to 39 years with certain brain cancers including newly diagnosed high-grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), and recurrent medulloblastoma (MB). This phase II trial aims to assess how effective and safe this vaccine, which targets CMV antigens, might be for these patients. The study is divided into three groups based on the type of tumor and treatment status, each with its own goals and analysis methods. Participants first receive a course of chemotherapy with temozolomide for five days, followed by the PEP-CMV vaccine administered intradermally in the groin area. Before the vaccine, patients get a tetanus-diphtheria (Td) booster and a small preconditioning Td vaccine to prepare the immune system. The first cycle lasts about 77 days, with vaccines given at weeks 3, 5, and 7, then monthly vaccines continue every 28 days for up to 24 cycles. The vaccine dose is carefully measured and mixed with an immune-boosting oil emulsion. During the study, participants undergo regular assessments including MRI scans and clinical evaluations to monitor tumor response and safety. Researchers measure progression-free survival over four months for recurrent medulloblastoma, and one-year survival or progression-free survival for DIPG and HGG groups. Patients’ organ function, neurological status, and overall health are closely evaluated throughout treatment, and the trial continues until the last scheduled visit or until treatment discontinuation. The total duration varies depending on the number of vaccine cycles received.
CONDITIONS
Brief 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 enrollment
- Diagnosis of recurrent, progressive, or refractory medulloblastoma with measurable disease
- Newly diagnosed high-grade glioma or diffuse intrinsic pontine glioma within 42 days after radiation (for HGG and DIPG strata)
- Karnofsky or Lansky performance score of 50% or higher
- Adequate bone marrow, renal, liver, and neurological function
- Willingness to use medically acceptable birth control if of childbearing or child-fathering potential
- Signed informed consent prior to enrollment
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection requiring treatment
- Known HIV, HBV, or HCV infection
- Immunosuppressive disease or use of immunosuppressive agents (except inhaled corticosteroids for asthma)
- Receiving tumor-directed therapy or other investigational drugs
- High dose dexamethasone use above specified limits
- Clinically significant unrelated systemic illness
- Inability to return for follow-up visits or assessments
- High risk for imminent neurologic decline due to extensive disease or brain shift on MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles; Cycle 1 lasts 77 ± 2 days, subsequent cycles last 28 days each
Participants receive standard chemotherapy with temozolomide for five days, followed by the PEP-CMV vaccine. They also receive a tetanus diphtheria (Td) booster vaccine at enrollment and a small dose Td preconditioning vaccine 6-24 hours before the first PEP-CMV vaccine. The first 3 PEP-CMV vaccines are given every 2 weeks during the 77-day first cycle, then monthly vaccines for up to 24 cycles.
3 vaccine visits every 2 weeks during the first 77-day cycle, then monthly vaccine visits for up to 21 additional cycles
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
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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