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

Inclusion Criteria

• Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory
• Patients must have failed standard therapy and at the time of study entry have recurrent, progressive or refractory disease with no known curative options
• 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
• 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
• Patient must have received last dose of known myelosuppressive chemotherapy > 21 days prior to enrollment; > 42 days if nitrosurea
• 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
• Immunomodulatory treatment - patient must have received last dose > 21 days prior to enrollment
• Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
• 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
• 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
• Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment
• 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
• Absolute neutrophil count >= 1.0 x 10^9/L
• Platelets >= 100 x 10^9/L (transfusion dependent)
• Hemoglobin >= 8 g/dl (may receive transfusions)
• Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 times institutional upper limit of normal
• Albumin >= 2 g/dl
• 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)
• Patients must have minimum head circumference of 44 cm
• 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
• Female patients of childbearing potential must have a negative serum or urine pregnancy test
• 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
• 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
• If patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollment

Exclusion Criteria

• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
• Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient’s first malignancy has been in remission for at least 5 years from the end of treatment
• Patients who are receiving any other anticancer or investigational drug therapy are not eligible
• Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to device usage plan, other study procedures, and study restrictions
• Patients with primarily infra-tentorial or spinal cord tumor are not eligible
• Patients for who clinical suspicion is present of metastatic disease in the cerebrospinal fluid (CSF) or spine must have magnetic resonance imaging (MRI) of spine and CSF obtained (lumbar puncture or through Ommaya, external ventricular drain [EVD] or shunt) with negative cytology; patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible
• Patients with major skull defects (such as missing bone without replacement) are not eligible
• Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed
• Patients with pacemaker, defibrillator, or documented significant arrhythmia, are not allowed
• Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters
• Patients with history of hypersensitivity to conductive hydrogel are not eligible