Abstract CT092: Effect of tumor treating fields in children with recurrent or progressive high-grade glioma and ependymoma; Pediatric Brain Tumor Consortium PBTC048

Abstract

Abstract Background: Current treatment regimens show poor prognosis in recurrent or progressive pediatric CNS tumors. Children with high-grade gliomas (HGG) after progression cannot be cured, with reported median survival <1-2 years. Overall survival (OS) of pediatric recurrent/progressive ependymoma is also poor. Tumor Treating Fields (TTFields) is an anti-mitotic cancer therapy for the treatment of recurrent (supratentorial) glioblastoma (GB). A phase 3 clinical trial in adults with newly-diagnosed GB was stopped early due to significant improvements of event-free (EFS) and OS in patients receiving TTFields in conjunction with temozolomide. A separate phase 3 trial comparing TTFields monotherapy with physician's choice chemotherapy in adults with recurrent GB demonstrated comparable OS and improved quality-of-life (QoL). Methods: This multicenter feasibility trial [NCT03033992] will examine the feasibility and device-related toxicity of TTFields in children aged 5-21 years with supratentorial HGG and ependymoma. The secondary objectives include: response rate, event-free survival, compliance and QoL. To establish feasibility Optune device will need to be worn ≥18 hours/day for at least 23/28 days of cycle one. Patients will have a brain MRI with/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. Treatment may continue up to 26 cycles based on observed benefit and safety. A sample size of 20 patients is planned with an interim analysis after the first 11 patients. Kaplan-Meier estimates of EFS for all eligible patients will be provided separately for the HGG and ependymoma cohorts. The rates of confirmed sustained objective responses (CR+PR) observed during treatment will be estimated. All PROMIS and Neuro-QoL scores will be reported using T-score matrix (mean=50; SD=10). The projected accrual rate is 1.5-2.5 patients per month with a follow-up for 2 years. The study is currently accruing patients. Citation Format: Stewart Goldman, Arzu Onar-Thomas, Ira Dunkel, Eugene Hwang. Effect of tumor treating fields in children with recurrent or progressive high-grade glioma and ependymoma; Pediatric Brain Tumor Consortium PBTC048 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT092.