Abstract
Abstract Background Recurrent or progressive pediatric CNS tumors have a poor prognosis under current treatment regimens. For children with high-grade gliomas (HGG), once progression occurs, most patients cannot be cured, and median survival remains < 1-2 years; overall survival of recurrent/progressive ependymoma is also poor in children. Tumor Treating Fields (TTFields) is an anti-mitotic cancer therapy for the treatment of recurrent (supratentorial) glioblastoma (GB).) A phase 3 clinical trial comparing TTFields monotherapy with physician’s choice chemotherapy in adult patients with recurrent GB demonstrated comparable overall survival and improved quality of life. In this multicenter feasibility trial we plan to examine the feasibility and device-related toxicity of TTFields in children with supratentorial HGG and ependymoma. The secondary objectives include: response rate, Event-Free Survival, compliance on use of device and Quality of Life (QoL) of tehe children (aged 8+) and families. Methods The Optune device will be worn ≥ 18 hours/day for at least 23 days out of 28 days of cycle one. Patients will have Brain MRI with and without contrast performed prior to therapy, after cycles 2, 4, 6, 9, then every 3 cycles thereafter until time of progression or completion of treatment. For those patients who complete at least 9 cycles of therapy, an MRI will be performed every 3 cycles for 2 years then every 4 months after completion of treatment.Treatment may continue up to 26 cycles pending observed benefit and safety. A sample size of 20 patients is needed with an interim analysis conducted after the first 11 patients. Kaplan-Meier estimates of EFS for all eligible patients who use the device for < 1 day will be provided separately for the HGG and Ependymomahistology-based cohorts. We will also estimate the rates of confirmed sustained objective responses (CR+PR) observed during treatment. All PROMIS and Neuro-QoL scores will be reported using T-score matrix (mean=50 and SD=10). The projected accrual rate is 1.5-2.5 patients per month. Patients will be followed for 2 years. Citation Format: Stewart Goldman, Arzu Onar-Thomas, Ira Dunkel, Eugene Hwang. Tumor treating fields in pediatric recurrent high-grade glioma and ependymoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr CT051. doi:10.1158/1538-7445.AM2017-CT051
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
