A Pilot Study of SurVaxM in Children and Young Adults with Progressive or Relapsed Medulloblastoma, High-Grade Glioma, or Ependymoma or Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Share

Full Title

A Pilot Study of Safety, Tolerability, and Immunological Effects of SurVaxM in Pediatric Patients with Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (PBTC-060) (CIRB)

Purpose

The purpose of this study is to assess a vaccine called SurVaxM in children and young adults with medulloblastoma, high-grade glioma, or ependymoma that has continued to grow or came back despite treatment, as well as in young patients newly diagnosed with diffuse intrinsic pontine glioma.

While vaccines are usually thought of as ways to prevent diseases, they can also be used to treat cancer. SurVaxM is designed to tell the immune system to look for tumor cells that contain a protein called survivin and destroy them. The survivin protein may be found on most glioblastomas and other types of cancer, but is not found in normal cells. If the immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.

There are two phases to this study. The “priming” phase involves four doses over a six-week period of the vaccine plus other medications that help boost the immune response. Patients who respond well to this treatment can continue to a maintenance phase, when they will receive the vaccine and immune-boosting medications every eight weeks for up to two years.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have medulloblastoma, high-grade glioma, or ependymoma that has continued to grow or came back despite treatment.
  • Patients newly diagnosed with diffuse pontine glioma will be eligible to participate after the initial part of the study is completed and has shown that the treatment is safe in the patients with recurrent brain tumors.
  • The serious side effects of previous therapies must go away before the study treatment is given.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 1-21.

For more information about this study and to ask about eligibility, please call 833-MSK-KIDS.

Protocol

22-065

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04978727