Optune Device for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the Optune NovoTTF-200A device can safely work with chemotherapy to treat certain types of brain cancer in children. It focuses on high-grade gliomas and ependymomas, which are aggressive brain tumors. The trial seeks children with a brain tumor that has returned or hasn't responded to other treatments and who have already undergone surgery and radiation. Participants must have a tumor in the supratentorial area of the brain, which the device can target. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any anti-cancer therapy within 4 weeks before starting the trial, and you must not be using any other investigational drugs close to the start of the trial.
What prior data suggests that the Optune NovoTTF-200A device is safe for pediatric patients with brain cancer?
Research has shown that the Optune NovoTTF-200A, a device using electric fields to slow cancer cell growth, is generally safe for children with brain tumors. Studies have found no new safety issues when used in children. Those who have received this treatment have tolerated it well, with no major side effects reported. As this trial is in its early stages, the primary focus is on ensuring safety, so extensive safety data may not yet be available. However, the results so far are promising for potential participants.12345
Why do researchers think this study treatment might be promising?
The Optune NovoTTF-200A System is unique because it uses a novel method called tumor treating fields (TTF) to combat brain cancer. Unlike standard treatments such as chemotherapy or radiation, which target cancer cells through chemicals or radiation, Optune delivers low-intensity alternating electric fields directly to the tumor site. This disrupts cancer cell division and growth while sparing healthy cells. Researchers are excited because this non-invasive approach offers a new way to target recurrent high-grade gliomas and ependymomas, potentially enhancing treatment effectiveness and reducing side effects.
What evidence suggests that the Optune NovoTTF-200A device is effective for brain cancer?
Studies have shown that the Optune NovoTTF-200A device can help treat brain tumors by using electric fields to stop cancer cells from dividing. Research indicates that this device is already effective for adults with glioblastoma multiforme, a type of aggressive brain cancer. In adults, using Optune along with chemotherapy has improved survival rates and slowed tumor growth. In this trial, participants with recurrent high-grade gliomas and ependymomas will receive treatment with the Optune NovoTTF-200A system as monotherapy. Early studies in children are examining its safety and potential synergy with chemotherapy. Although data on children remains limited, the device’s success in adults offers hope for treating similar brain tumors in younger patients.14567
Who Is on the Research Team?
Derek Hanson, MD
Principal Investigator
Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center
Are You a Good Fit for This Trial?
This trial is for pediatric patients with recurrent high-grade glioma or ependymoma brain tumors. Participants must have had prior tumor resection and radiation, be able to undergo MRI scans, and have adequate organ function. They should not have serious side effects from previous treatments, implanted electronic devices in the brain, significant bleeding disorders, or be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Optune NovoTTF-200A System along with Temozolomide and Bevacizumab in 28-day cycles. Initial safety evaluation occurs over the first two cycles.
Extended Treatment
Participants continue treatment in 28-day cycles for up to 12 cycles or until clinical criteria for discontinuation are met. Treatment may continue beyond 12 cycles if approved.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with overall survival and progression-free survival assessed.
What Are the Treatments Tested in This Trial?
Interventions
- Optune NovoTTF-200A System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hackensack Meridian Health
Lead Sponsor
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution