HGG-39. EFFECT OF TUMOR TREATING FIELDS IN CHILDREN WITH RECURRENT OR PROGRESSIVE HIGH-GRADE GLIOMA AND EPENDYMOMA (PEDIATRIC BRAIN TUMOR CONSORTIUM PBTC048)

ABSTRACT: Abstract Prognosis is poor in recurrent or progressive pediatric CNS tumors. Children with high-grade gliomas (HGG) after progression cannot be cured; reported median survival is <1-2 years. Overall survival (OS) of pediatric recurrent/progressive ependymoma is also poor. Tumor Treating Fields (TTFields) is an approved anti-mitotic cancer therapy for newly diagnosed and recurrent (supratentorial) glioblastoma (GB). A phase 3 trial in adults with newly-diagnosed GB showed significantly improved event-free (EFS) and OS in patients receiving TTFields plus temozolomide. A phase 3 trial recurrent GB of TTFields monotherapy versus physician’s choice chemotherapy in adults demonstrated comparable OS and improved quality-of-life (QoL). This multicenter trial [NCT03033992] will examine the feasibility and toxicity of TTFields in children (5-21 years) with supratentorial HGG and ependymoma. Secondary objectives include: response rate, EFS, compliance and QoL. The Optune device will be worn ?18 hours/day for at least 23/28 days of cycle one. Patients will have brain MRIs with/without contrast prior to therapy, after cycles 2, 4, 6, 9, then every 3 cycles thereafter until progression or treatment completion. Treatment may continue up to 26 cycles based on observed benefit/safety. A sample size of 20 patients is planned with an interim analysis after the first 11 patients. Kaplan-Meier estimates of EFS for eligible patients will be provided separately for HGG and ependymoma cohorts. Rates of confirmed sustained objective responses (CR+PR) during treatment will be estimated. All PROMIS and Neuro-QoL scores will be reported using T-score matrix (mean=50; SD=10). The accrual rate is 1.5-2.5 patients/month with a 2-year follow-up.

SUBMITTER: Goldman S 

PROVIDER: S-EPMC6012917 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature