PBTC48: Study of the Optune Device in Children with Certain High-Grade Glioma and Ependymoma Brain Tumors

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

Category:

Brain Tumor

Diseases Treated:

High-grade glioma (HGG), ependymoma

Eligibility Overview:

  • Between 5 and 21 years old
  • Diagnosis of supratentorial high-grade glioma (HGG) or supratentorial ependymoma that is recurrent, progressive or refractory
  • Head circumference of at least 44 cm
  • Failed standard therapy with no other available treatment options
  • Recovered from prior chemotherapy, immunotherapy or radiotherapy
  • Willing and able to use the device at least 18 hours a day for at least 23 days and keep head shaved throughout treatment
  1. Brief Summary

    The overall survival of children with recurrent or progressive ependymoma and high-grade gliomas is poor. This multicenter feasibility trial will test the Optune System, a battery-powered device that produces low-intensity, intermediate frequency alternating electrical fields by means of transducer arrays placed on the shaved scalp. These tumor treating fields (TTFields) impair the growth of tumor cells. The U.S. Food and Drug Administration (FDA) has approved the Optune System for treatment of newly diagnosed- and recurrent glioblastoma in adults. The device has not been tested in children.

    Parents and patients will be trained how to use the Optune device at home. Participants must be able to wear the device a minimum of 18 hours a day for at least 23 days in a 28-day cycle. Treatment may continue up to 26 cycles if the participant is benefitting from the treatment and has no significant related toxicity. Patients will be followed for 2 years after the study treatment period ends.

    Primary Objective

    To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma

    To describe the Optune device treatment-related toxicities in these children

    Eligibility Criteria

    Inclusion criteria include:

    • Between 5 and 21 years old
    • Diagnosis of supratentorial high-grade glioma (HGG) or supratentorial ependymoma that is recurrent, progressive or refractory
    • Head circumference of at least 44 cm
    • Failed standard therapy with no other available treatment options
    • Recovered from prior chemotherapy, immunotherapy or radiotherapy
    • Willing and able to use the device at least 18 hours a day for at least 23 days and keep head shaved throughout treatment
    • Score of at least 60 on Karnofsky Performance Scale (patients older than 16) or Lansky Performance Score (age 16 and younger)
    • Adequate organ and marrow function

    Exclusion Criteria include:

    • Pregnancy
    • History of any other malignancy
    • Receiving any other anticancer or investigational drug therapy
    • Unable or unwilling to return for follow-up visits or comply with protocol
    • Primarily infra-tentorial or spinal cord tumor
    • Use of pacemaker, defibrillator or documented significant arrhythmia

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. About this study

    This study will test the safety of an experimental medical device in children with certain kinds of brain tumors that have grown or come back after treatment. The device is called the Optune System. It is a portable device operated by a battery or other power-supply. The device produces changing electrical fields, called tumor treatment fields (TTFields), within the human body. TTFields are applied to the patient’s head by large, sticky patches. TTFields have 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.

    Purpose of this clinical trial

    The main purpose of this study is to see if the Optune System is safe to use in children. Researchers also want to find out if children are able to wear the device as instructed.

    Eligibility overview

    • Between 5 and 21 years old
    • Diagnosis of supratentorial high-grade glioma (HGG) or supratentorial ependymoma that is recurrent, progressive or refractory
    • Head circumference of at least 44 cm
    • Failed standard therapy with no other available treatment options
    • Recovered from prior chemotherapy, immunotherapy or radiotherapy
    • Willing and able to use the device at least 18 hours a day for at least 23 days and keep head shaved throughout treatment
  3. PBTC48 Quick View
    Sponsors Pediatric Brain Tumor Consortium
    ClinicalTrials.gov identifier NCT03033992
    Trial Start Date January 2017
    Estimated Enrollment 25 (5 at St. Jude)
    Study Type Interventional
    Conditions High-Grade Glioma, Ependymoma
    Ages 5 to 21 years old
    Principal investigator Anna Vinitsky, MD, MS
    Study Sites St. Jude Children's Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss PBTC48 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

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.