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Device

Optune Device for Brain Cancer

Phase 1
Waitlist Available
Led By Derek Hanson, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study entry
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a device using electric fields, combined with two drugs, can help children with aggressive brain tumors that have returned after treatment. The device stops cancer cells from growing, while the drugs damage the cancer cells and cut off their blood supply. This approach has been tested for many years and is used for various types of cancer, combining electric pulses with chemotherapy drugs to increase their effectiveness.

Who is the study for?
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.
What is being tested?
The study tests the safety of using the Optune NovoTTF-200A device alongside chemotherapy in children with specific types of brain tumors. The device delivers electric fields intended to disrupt cancer cell growth while patients also receive standard drug treatment.
What are the potential side effects?
Potential side effects may include skin irritation beneath device pads, headaches, malaise due to wearing the device for long periods, and typical chemotherapy-related issues like nausea, fatigue, lowered blood counts increasing infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after study entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of the Optune NovoTTF-200A System when used alone in pediatric patients with recurrent high-grade gliomas.
Tolerability of the Optune NovoTTF-200A System when used alone in pediatric patients with recurrent high-grade gliomas.
Secondary study objectives
Assess the overall survival of patients treated on this study protocol to aid in the future development of pediatric phase II/III studies using the Optune NovoTTF-200A System.
Assess the progression free of patients treated on this study protocol to aid in the future development of pediatric phase II/III studies using the Optune NovoTTF-200A System.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Recurrent high grade gliomas and ependymomasExperimental Treatment1 Intervention
Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for brain tumors include radiation therapy, chemotherapy, and Tumor Treating Fields (TTFields). Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow. Chemotherapy, such as temozolomide, interferes with the DNA replication process, leading to cell death. TTFields disrupt cancer cell division by delivering alternating electric fields, which interfere with the mitotic process. These mechanisms are crucial for brain tumor patients as they target the rapid and uncontrolled growth of tumor cells, aiming to improve survival rates and quality of life.
Tumor Treating Fields in the Management of Patients with Malignant Gliomas.Editorial: what is new in the treatment of gliomas?

Find a Location

Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor
62 Previous Clinical Trials
5,984 Total Patients Enrolled
Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,315 Total Patients Enrolled
Derek Hanson, MDPrincipal InvestigatorJoseph M. Sanzari Children's Hospital at Hackensack University Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Optune NovoTTF-200A System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03128047 — Phase 1
Brain Tumor Research Study Groups: Recurrent high grade gliomas and ependymomas
Brain Tumor Clinical Trial 2023: Optune NovoTTF-200A System Highlights & Side Effects. Trial Name: NCT03128047 — Phase 1
Optune NovoTTF-200A System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03128047 — Phase 1
~1 spots leftby Dec 2025