A Feasibility Study of the Optune Electric Field Device to Treat Children with Recurrent or Persistent Supratentorial High-Grade Gliomas and Ependymomas

Full Title

PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the Optune device for treating children with supratentorial high-grade gliomas and ependymomas that have come back or continued to grow despite prior treatment. Optune is worn on the head and delivers electrical fields called “tumor treatment fields” that are intended to destroy brain cancer cells.

The device will be worn for a minimum of 18 hours each day, with a recommended duration of 22 hours a day for at least 23 days of each 28-day cycle. The treatment will continue for up to 26 cycles if the child is experiencing a benefit and no significant side effects.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be at least 5 years of age and no older than 21.
  • Patients must have a supratentorial high-grade glioma or ependymoma that has come back or continued to grow despite treatment and cannot be cured with standard therapies.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • A patient’s neurological status needs to be stable for at least 1 week before entering the study.

For more information about this study and to inquire about eligibility, please contact Dr. Kevin De Braganca at 212-639-3449.

Protocol

17-304

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators