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.

Eligibility

1. Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory
2. Patients must have failed standard therapy and at the time of study entry have recurrent, progressive or refractory disease with no known curative options
3. Subjects must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two planes * This disease must be located primarily in the supratentorial region * Patients with significant disease that is metastatic outside of the supratentorial region are ineligible
4. Patients must have recovered from the acute treatment related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
5. Patient must have received last dose of known myelosuppressive chemotherapy > 21 days prior to enrollment; > 42 days if nitrosurea
6. Biologic agent - must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent > 7 days prior to study enrollment * For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
7. Immunomodulatory treatment - patient must have received last dose > 21 days prior to enrollment
8. Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
9. Patients must have had their last fraction of: * Craniospinal irradiation (> 24 Gy) > 3 months prior to enrollment * Focal irradiation > 42 days prior to enrollment * Local palliative irradiation (small port) > 14 days
10. Optune device application start date must be at least 4 weeks (28 days) from central nervous system (CNS) surgical procedure; excluding ventriculoperitoneal (VP) shunts, endoscopic third ventriculostomy (ETV) for which treatment could start 10 days post procedure; non-CNS surgical procedures such as but not limited to central venous catheter insertion at the discretion of treating physician and study chair
11. Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment
12. Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of enrollment must be >= 60; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
13. Absolute neutrophil count >= 1.0 x 10^9/L
14. Platelets >= 100 x 10^9/L (transfusion dependent)
15. Hemoglobin >= 8 g/dl (may receive transfusions)
16. Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
17. Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal
18. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 times institutional upper limit of normal
19. Albumin >= 2 g/dl
20. Serum creatinine based on age/gender; patients that do not meet the criteria but have a 24 hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible: * 2 to < 6 years: 0.8 mg/dL (male and female) * 6 to < 10 years: 1 mg/dL (male and female) * 10 to < 13 years: 1.2 mg/dL (male and female) * 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female) * >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
21. Patients must have minimum head circumference of 44 cm
22. Patients must be willing to use the Optune device >= 18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment
23. Female patients of childbearing potential must have a negative serum or urine pregnancy test
24. Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
25. The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines
26. If patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollment

Treatment Sites in Georgia