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Device

Optune System for Pediatric Brain Cancer

N/A

Recruiting

Led By Eugene Hwang, MD

Research Sponsored by Pediatric Brain Tumor Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Compliance in Optune Device Usage: Stratum 1: 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. Stratum 2: During concurrent Optune therapy and RT, patients must be willing to use the Optune device ≥18 hours/day for at least 40 of the 49 days of the duration of the feasibility period. During subsequent cycles of Optune therapy alone, patients must be willing to use the Optune device ≥18 hours/day for at least 23 days in a 28-day cycle. During concurrent Optune therapy and RT and Optune therapy alone, patients must be willing to keep their head shaved throughout treatment.

Must not have

Tumor Dissemination: Patients for whom clinical suspicion is present of metastatic disease in the CSF or Spine must have MRI of Spine and CSF obtained with negative cytology. Patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible.

Stratum 1 Tumor Location: Patients with primarily infra-tentorial or spinal cord tumor are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a device that uses electric fields can help treat brain tumors in young patients.

Who is the study for?

This trial is for children with high-grade glioma or ependymoma (5-21 years old) and those with newly diagnosed DIPG (3-21 years old). Participants must have stable neurological deficits, measurable disease, and meet specific organ function criteria. They should not have received certain prior treatments within specified time frames and must be willing to use the Optune device extensively.

What is being tested?

The study tests the Optune device's safety and effectiveness in two groups: one with supratentorial high-grade glioma or ependymoma using Optune alone, another with newly diagnosed DIPG using both Optune and radiation therapy. The goal is to see if this treatment can help manage these brain tumors in children.

What are the potential side effects?

Potential side effects of the Optune system may include irritation at the application site, headache, malaise, muscle twitching, fall risk due to carrying the device components. Radiation therapy may cause skin changes where treated, fatigue, nausea or hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to use the Optune device for the required hours and keep my head shaved.

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I am between 3 and 21 years old.

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My blood counts and liver/kidney functions are within required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tests show no cancer cells in my spinal fluid or spine.

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My cancer is not mainly in the lower part of my brain or spinal cord.

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I am not currently on any other cancer treatments or experimental drugs.

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I have had another type of cancer in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ependymoma

Therapeutic procedure

The feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.

+2 more

Secondary study objectives

Compliance rate

The Event-Free Survival

The Quality of Life Scores

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (Optune System)Experimental Treatment1 Intervention

Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory. All patients will use the study device Optune System (Tumor Treating Fields, TTFields).

Group II: Treatment (Concurrent Optune/focal radiation therapy followed by Optune-only therapy)Experimental Treatment1 Intervention

Patients must have newly diagnosed DIPG (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, without histologic confirmation; atypical DIPG undergoing a biopsy and the tumor is a diffuse glioma WHO Grade II-IV with OR without H3 K27M mutation; or pontine lesions that do not meet these MR imaging criteria with histologically confirmed diffuse glioma WHO Grade II-IV with H3 K27M- mutation). This arm will consist of two parts: a phase I component to evaluate the safety and tolerability of concurrent Optune and RT, and a phase II component to evaluate the feasibility of concurrent Optune and RT and the efficacy associated with this approach compared to historical controls.

0 / 8Eligibility criteria met