The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely
used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma
This phase I trial will utilize a standard 3+3 design to determine the safety and
tolerability of the Optune NovoTTF-200A System in pediatric patients with recurrent
high-grade glioma end ependemomas.
Patients will receive treatment with the Optune NovoTTF-200A System along with Temozolomide
and Bevacizumab and will consist of children with recurrent high-grade gliomas and
Ependamomas. Patients enrolled will receive treatment with the Optune NovoTTF-200A with
200kHz for a minimum of 18 hours per day in 28 day cycles as monotherapy. Phase I safety
evaluation will take place over the initial two cycles (56 days) of treatment. Following the
completion of the safety evaluation period, patients will continue to receive treatment in 28
day cycles, which may be repeated continuously without therapy interruption for 12 cycles or
until clinical criteria for discontinuation are met. Patients how appear to benefit from this
treatment may be allowed to continue treatment beyond 12 cycles if approved by the study
High Grade Glioma,
Optune NovoTTF-200A System
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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