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