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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Compliance rate

The Event-Free Survival

The Quality of Life Scores

+5 more

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 / 4Eligibility criteria met

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Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor

57 Previous Clinical Trials

4,652 Total Patients Enrolled

1 Trials studying Ependymoma

6 Patients Enrolled for Ependymoma

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN

8 Previous Clinical Trials

605 Total Patients Enrolled

4 Trials studying Ependymoma

417 Patients Enrolled for Ependymoma

Pediatric Brain Tumor ConsortiumLead Sponsor

37 Previous Clinical Trials

1,502 Total Patients Enrolled

7 Trials studying Ependymoma

544 Patients Enrolled for Ependymoma

Media Library

Optune System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03033992 — N/A

Ependymoma Research Study Groups: Treatment (Concurrent Optune/focal radiation therapy followed by Optune-only therapy), Treatment (Optune System)

Ependymoma Clinical Trial 2023: Optune System Highlights & Side Effects. Trial Name: NCT03033992 — N/A

Optune System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03033992 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For which type of individuals is this research study most advantageous?

"This clinical trial is searching for 80 individuals aged between 3 and 21 suffering from ependymoma. Further, the following criteria are mandatory: Age of enrolment must fit into Stratum 1 (> 5 years but ≤ 21) or Stratum 2 (>3 years but ≤21), histologic confirmation for supratentorial high-grade gliomas/ependymomas that are recurrent, progressive, or refractory; typical DIPG (MR imaging with a pontine epicenter and diffuse involvement of more than two-thirds of pons) without biopsy if eligible; disease primarily located in supratentorial region"

Answered by AI

Is the age requirement for enrollment in this trial above fifty years?

"This clinical trial allows patients between 3 and 21 years old to participate. There are 155 trials for minors, and an additional 244 studies available to those over 65."

Answered by AI

How many clinical facilities are currently participating in this trial?

"This trial is recruiting patients at 10 different medical centres, including Children's Hospital Los Angeles in LA, the Ann and Robert H. Lurie Children's Hospital of Chicago in Chicagoland , and Washington-based Children's National Medical Center; other locations are also available."

Answered by AI

Are there vacancies available for participants in this clinical experiment?

"According to clinicaltrials.gov, this trial has not been looking for patients since September 16th 2022. Although the study is no longer recruiting participants, there are 379 other medical experiments actively seeking volunteers at present."

Answered by AI

What are the fundamental goals of this experiment?

"The primary assessment of this medical trial, over a period of 5 years, is to identify the adverse effects associated with Optune device treatment in young patients suffering from recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. Secondary outcomes include analysing the correlation between apparent diffusion coefficient values within the tumour and response rate & event-free survival; quantifying tumor-type specific ADC value at baseline, during treatment, and amongst responders versus those with progressive diseases; calculating response rate based on bi-dimensional measurement before & after intervention; measuring event-free survival beginning from initial treatment till"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03033992.

All > Ependymoma