Study of PEP-CMV Vaccine for Treating Newly Diagnosed Pediatric Brain Tumors and Recurrent Medulloblastoma

Phase: Recruiting

First Posted: December

Condition(s): Diffuse Intrinsic Pontine Glioma (DIPG), High Grade Gliomas, Medulloblastoma

NCT Number: NCT05096481 Other Study ID Number(s): CONNECT1906

What Is the Purpose of This Study?

The purpose of this phase 2 study is to see if a cancer vaccine (PEP-CMV) can help patients’ immune system fight against high-grade glioma and medulloblastoma. We think PEP-CMV, which is an immunotherapy given as an injection into the thigh, can benefit children by training their immune system to seek out and attack these tumors.

Who Can Take Part in This Study?

People who may be eligible for this study:

  • Patients who are ≥3 and ≤25 years of age at the time of study enrollment.
  • Diagnosis: Patients who have a diagnosis of medulloblastoma that is recurrent, progressive or refractory.
  • All patients must have histological verification of a medulloblastoma, at original diagnosis or relapse.

For a full list of eligibility requirements, visit https://www.clinicaltrials.gov/study/NCT05096481

What Will Happen During This Study?

  • This study is designed for patients with diffuse intrinsic pontine glioma (DIPG) or malignant glioma (WHO grade 3 or 4) who are newly diagnosed (within 6 weeks of finishing radiation) OR patients with medulloblastoma whose tumor has come back at any point after having received radiation.
  • Patients on this study receive a single, 5-day course of oral chemotherapy called temozolomide, which is designed to condition the immune system, followed by PEP-CMV injections every 2 weeks for 3 vaccines, then monthly.

Principal Investigator

Maryam Fouladi
MD

Hematology & Oncology

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