Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG

Running, not enrolling · Not applicable

Conditions studied: Malignant Glioma, Ependymoma, Diffuse Intrinsic Pontine Glioma

In brief

This is a multicenter trial of the Optune device to examine the feasibility and to describe the device-related toxicity in children with supratentorial high grade glioma (HGG) or ependymoma (Stratum 1) and to examine the feasibility and efficacy of concurrent Optune and standard focal radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2).

Key facts

Study ID

NCT03033992

Run by

Children's Oncology Group

People needed

80

Starts

2017-04-04

Expected to finish

2032-07-22

Last updated by the study team

2026-06-02

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: at the time of enrollment Stratum 1: ≥ 5 years but ≤ 21 Stratum 2: ≥ 3 years but ≤ 21
• Diagnosis:
• Stratum 1: Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory.
• Stratum 2: Patients with newly diagnosed DIPG
• Patients with a typical DIPG on MR imaging, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation.
• Note: Patients with typical DIPG who undergo a biopsy are eligible provided the tumor is a diffuse glioma WHO Grade II-IV with OR without H3 K27M mutation.
• Patients with pontine lesions that do not meet these MR imaging criteria will be eligible if there is histologic confirmation diffuse glioma WHO Grade II-IV with H3 K27M-mutation.
• Disease Status: Patients must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two planes
• Stratum 1:
• This disease must be located primarily in the supratentorial region
• Patients with significant disease that is metastatic outside of the supratentorial region are ineligible
• Stratum 2:
• This disease must be located primarily in the pons
• Prior Therapy:
• Stratum 1: 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.
• Stratum 2: Patients may not have had any prior antitumor therapy except surgery and/or steroids.
• Myelosuppressive Chemotherapy: Patients must have received last dose of known myelosuppressive chemotherapy >21 days prior to enrollment; >42 days if nitrosourea.
• Biologic Agent: 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 the last dose >21 days prior to enrollment.
• Monoclonal antibody treatment and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment. Radiation:
• Stratum 1: Patients must have had their last fraction of:
• Craniospinal irradiation (>24Gy) or total body irradiation or radiation to ≥ 50% of pelvis ≥ 42 days prior to enrollment
• Focal irradiation ≥ 14 days prior to enrollment
• Local palliative irradiation (small port) ≥ 14 days

You may not qualify if…

• Systemic Illness: 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.
• Other Malignancy: Patients with a history of any other malignancy.
• Concurrent Therapy: Patients who are receiving any other anticancer or investigational drug therapy are not eligible.
• Inability to Participate: 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.
• Stratum 1 Tumor Location: Patients with primarily infra-tentorial or spinal cord tumor are not eligible.
• Tumor Dissemination: Patients for who clinical suspicion is present of metastatic disease in the CSF or Spine must have MRI of Spine and CSF obtained (Lumbar puncture or through ommaya, EVD or Shunt) with negative cytology. Patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible.
• Skull Defects: Patients with major skull defects (such as missing bone without replacement) are not eligible.
• Neurological Disorder: 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 eligible.
• Cardiac Disorder: Patients with pacemaker, defibrillator, or documented significant arrhythmia, are not allowed.
• Intracranial Objects: Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters.
• Allergy: Patients with history of hypersensitivity to conductive hydrogel are not eligible.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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