Optune Delivered Electric Field Therapy in Treating Children with Recurrent, Progressive, or Refractory High-Grade Glioma or Supratentorial Ependymoma

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT03033992
Trial Phases:		Protocol IDs:	PBTC-048 (primary) PBTC-048 NCI-2016-00926 PBTC-048
Eligibility:	5 - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Pediatric Brain Tumor Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03033992

Summary

This clinical trial studies the side effects and how well Optune delivered electric field therapy works in treating children with high-grade glioma or supratentorial ependymoma that has come back, is getting worse, or does not respond to treatment. The Optune device is worn on the head and produces changing electrical fields that may break up and kill tumor cells.

Objectives

PRIMARY OBJECTIVES:
I. To establish the feasibility of treatment with the Novo TTF-100A device (Optune device) in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.
II. To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.

SECONDARY OBJECTIVES:
I. To estimate the response rate and event-free survival (EFS) as markers of anti-tumor activity of the Optune device within the context of a feasibility trial.
II. To assess the association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study.
III. To explore the impact of the Optune device on the children and families undergoing this therapy, and to explore the association between demographic (e.g., socioeconomic status [SES], gender), disease (e.g., risk status), treatment, and behavioral variables with health-related quality of life (QoL) changes.
IV. To explore the association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS.

OUTLINE:
Patients undergo electric field therapy using the NovoTTF-100A device 18-22 hours daily (QD) on days 1-35 of course 1 and at least 23 days QD of subsequent courses. Treatment repeats every 35 days for course 1 and every 28 days for subsequent courses for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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