Optune Device for Brain Cancer

Recruiting at 1 trial location

Overseen By Sherri Mayans, APN

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Hackensack Meridian Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 56 days

7 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is the Optune device generally safe for humans?

The Optune device, which delivers alternating electrical field therapy, has been used in clinical trials for glioblastoma and is generally considered safe for humans, with data indicating it may prolong survival in patients with this condition. ^{1 2 3 4 5}

How is the Optune treatment different from other treatments for brain cancer?

The Optune device is unique because it uses alternating electric fields, called Tumor Treating Fields (TTFields), to disrupt cancer cell division, unlike traditional treatments like chemotherapy or radiation. This non-invasive approach targets the tumor directly through transducer arrays placed on the scalp, offering similar effectiveness with fewer side effects compared to standard chemotherapy. ^{6 7 8 9 10}

Research Team

Derek Hanson, MD

Principal Investigator

Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center

Eligibility Criteria

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

I have a brain tumor that can be treated with TTFields despite having cancer spread to my lower brain or spinal cord.

Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment

All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section

Exclusion Criteria

I have no allergies to Chinese hamster ovary cell products or human antibodies.

I don't have severe side effects from past cancer treatments.

I agree to use effective birth control during and for 6 months after therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

56 days

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.

Up to 12 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, with overall survival and progression-free survival assessed.

Up to 2 years

Treatment Details

Interventions

• Optune NovoTTF-200A System

Trial Overview 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.

Participant Groups

Group I: Recurrent high grade gliomas and ependymomas Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

NovoCure Ltd.

Industry Sponsor

Trials

64

Recruited

6,100+

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

Findings from Research

Despite aggressive treatment options for glioblastoma, including surgery and chemotherapy, the median survival remains low at 14-16 months, highlighting the need for new therapeutic strategies.

Recent data suggest that the Optune™ device, which delivers alternating electrical field therapy, may improve survival in newly diagnosed glioblastoma patients, indicating a promising new approach alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? Domingo-Musibay, E., Galanis, E.[2022]

Optune® uses tumor-treating fields (TTFields) therapy, which is a novel approach to treating newly diagnosed glioblastoma (GBM) that differs from traditional methods, emphasizing the importance of continuous daily use for optimal patient outcomes.

Oncology nurses play a crucial role in educating patients about TTFields therapy, ensuring adherence to treatment, and helping patients integrate the use of Optune into their daily lives, which can enhance the effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optune®: Practical Nursing Applications. Murphy, J., Bowers, ME., Barron, L.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase 0 Clinical Trial of Everolimus in Patients with Vestibular Schwannoma or Meningioma. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Inhibitors of the mammalian target of rapamycin. [2021]

3. England pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

In Vitro Validation of Intratumoral Modulation Therapy for Glioblastoma. [2020]

5. Greece pubmed.ncbi.nlm.nih.gov

Preclinical analysis of MTOR complex 1/2 inhibition in diffuse intrinsic pontine glioma. [2019]

6. England pubmed.ncbi.nlm.nih.gov

NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Glioblastoma (GBM) with the Addition of Tumor-Treating Fields (TTF): A Review. [2020]

8. England pubmed.ncbi.nlm.nih.gov

NovoTTF-100A: a new treatment modality for recurrent glioblastoma. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Optune®: Practical Nursing Applications. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Stability of Programmable Shunt Valve Settings with Simultaneous Use of the Optune Transducer Array: A Case Report. [2020]