Phase 2 Study of PEP-CMV Vaccine for Children and Young Adults with Newly Diagnosed High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, or Recurrent Medulloblastoma

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.

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