RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma

Quick Facts

Study Start:2024-07-18
Study Completion:2030-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05096481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amy K Jones, MSN
CONTACT
6147223284
connect@nationwidechildrens.org

Principal Investigator

Eric Thompson, MD
STUDY_CHAIR
Duke University
Daniel Landi, MD
STUDY_CHAIR
Duke University
Maryam Fouladi, MD
STUDY_CHAIR
Nationwide Children's Hospital

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Eric Thompson, MD, STUDY_CHAIR, Duke University
  • Daniel Landi, MD, STUDY_CHAIR, Duke University
  • Maryam Fouladi, MD, STUDY_CHAIR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2030-06-15

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2030-06-15

Terms related to this study

Keywords Provided by Researchers

  • High Grade Glioma
  • Diffuse Intrinsic Pontine Glioma
  • Recurrent Medulloblastoma
  • Immunotherapy

Additional Relevant MeSH Terms

  • High Grade Glioma
  • Diffuse Intrinsic Pontine Glioma
  • Recurrent Medulloblastoma