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

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:o

Trial Details

NCT ID
NCT05096481
Phase
PHASE2
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • PEP-CMV
  • Temozolomide
  • Tetanus Diphtheria Vaccine
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Miami, Florida, United States|25.77427,-80.19366
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment
  • Diagnosis: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological veri…
  • Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI.
  • Metastatic Disease: Patients with M+ disease are eligible.

For full eligibility, visit ClinicalTrials.gov.

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