NCT03128047

HUMC 1612: Optune NovoTTF-200A System

HUMC 1612: A Phase I Trial of the Optune NovoTTF-200A System With Concomitant Temozolomide and Bevacizumab in Pediatric Patients With High-grade Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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 and ependemoma.

Detailed description

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 Principle Investigator.

Conditions

• High Grade Glioma
• Ependymoma

Interventions

Type	Name	Description
DEVICE	Optune NovoTTF-200A System	Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Timeline

• Start date: 2017-04-06
• Primary completion: 2024-07-08
• Completion: 2025-04-05
• First posted: 2017-04-25
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study