What side effects are associated with this type of intervention?

Common treatments for brain tumors, including Tumor Treating Fields (TTFields), chemotherapy, and radiation therapy, have various side effects. TTFields can cause skin irritation and mild to moderate headaches. Chemotherapy, such as temozolomide, often leads to nausea, fatigue, and increased risk of infections due to lowered blood cell counts. Radiation therapy can result in hair loss, cognitive decline, and fatigue. Surgical interventions may lead to neurological deficits depending on the tumor's location. These treatments aim to manage tumor growth but come with significant side effects that need to be monitored and managed.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including the Optune system, which uses Tumor Treating Fields (TTFields). TTFields are low-intensity, alternating electric fields that disrupt cancer cell division. Optune, in combination with temozolomide, was approved for newly diagnosed glioblastoma in 2015 and for recurrent glioblastoma in 2011. Other FDA-approved treatments for brain tumors include chemotherapeutic agents like temozolomide and bevacizumab, which target tumor growth and angiogenesis. These therapies represent significant advancements in the management of high-grade gliomas.

What other types of research exist?

Promising alternatives to Optune NovoTTF-200A for brain tumor patients include: 1) Bevacizumab, which has shown efficacy in reducing tumor growth and improving hearing in NF2-related vestibular schwannomas. 2) Everolimus, an mTORC1 inhibitor, which has demonstrated potential in treating progressive vestibular schwannomas and recurrent meningiomas. 3) Proton Beam Therapy (PBT), which may offer benefits over traditional photon-based radiotherapy, particularly in pediatric CNS malignancies and certain tumor types like large ocular melanomas and chordomas.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after study entry

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.

Do I qualify?Apply below to find out

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?