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PBTC48: Optune for High-Grade Glioma, Ependymoma, or Diffuse Intrinsic Pontine Glioma

About this study

This study will test the safety of an experimental medical device in children who have:

The medical device is called Optune. It works by sending mild electric fields to the brain. These electric fields may slow or stop cancer cells from growing. 

Patients wear a cap with electrodes connected to a small, portable device. It allows patients to do daily activities while receiving treatment. The device has been shown to stop the growth of certain types of tumor cells in adults with brain tumors.

The Optune device has been tested in adults but not in children.

Group 1 tests how well patients with high-grade glioma or ependymoma can use the Optune device and what side effects it may cause. We want to see if patients can wear the device for at least 18 hours a day for 28 days. We will also track any treatment-related issues. The study will continue for up to 26 cycles if the device helps and does not cause serious problems. After stopping treatment, patients will be monitored for 2 more years to check for long-term effects and disease progression.

Group 2 looks at how safe and effective it is to use Optune along with radiation therapy in patients with newly diagnosed DIPG. This part of the study has 2 phases: 

  • The first phase will test if the combined treatment is safe and well-tolerated.
  • The second phase will check if it is practical for patients to use the device for at least 40 out of 49 days during the first treatment cycle. 

If Optune helps and does not cause major side effects, patients can continue using it for up to 5 years, with follow-up for 3 years after stopping treatment.

Eligibility overview

  • Group 1
    • Patients with supratentorial high-grade glioma or supratentorial ependymoma that has come back, is progressing, or does not respond to treatment
    • 5–21 years old
  • Group 2
    • Patients with newly diagnosed DIPG
    • 3–21 years old
  • Patient is willing and able to use the device at least 18 hours a day during treatment

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

Optune for Children with High-Grade Glioma or Ependymoma, and Optune with Radiation Therapy for Children with DIPG

Study goal:

To see how well children with high-grade glioma and ependymoma can use the Optune device and what side effects it may cause; and to see if Optune and radiation therapy are safe and effective for diffuse intrinsic pontine glioma. 

Diagnosis:

High-grade glioma (HGG), ependymoma, DIPG

Age:

3-21 years

Clinical trials categories:

Childhood Cancer High-Grade Glioma Diffuse Intrinsic Pontine Glioma (DIPG) Ependymoma Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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