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Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

6 Participants Needed

Optune Device for Meningioma

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Investigational drugs

Disqualifiers: Other cancer, Pregnancy, Implanted device, others

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

Trial Summary

Do I need to stop my current medications for the Optune Device trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not be using any other investigational drugs or be part of another treatment trial.

Is the Optune device generally safe for humans?

The provided research articles do not contain specific safety data for the Optune device or similar treatments for meningioma or other conditions.¹ ² ³ ⁴ ⁵

How does the Optune treatment differ from other treatments for meningioma?

The Optune device is unique because it uses electric fields to disrupt cancer cell division, which is different from traditional treatments like surgery or radiation that physically remove or target the tumor. This non-invasive approach offers an alternative for patients who may not be candidates for surgery or have tumors that are resistant to other treatments.¹ ⁶ ⁷ ⁸ ⁹

What is the purpose of this trial?

The purpose of this study is to find out what effects, good or bad, the Optune device has on the patient and meningioma. This study is being done because currently there are no proven effective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The study uses an experimental device called Optune. Optune is "experimental" because it has not been approved by the U.S. Food and Drug Administration (FDA) for this type of tumor, although it has been approved for a different type of brain tumor.

Research Team

Thomas Kaley, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with recurrent atypical or anaplastic meningioma, who've had surgery and/or radiation but the tumor has grown back. They should be in stable health otherwise, have a life expectancy of at least 3 months, and not be on other clinical trials. Pregnant or breastfeeding individuals can't join, nor those with certain medical devices like pacemakers.

Inclusion Criteria

My recent scans show my tumor is growing.

My steroid dose has been stable or reduced for at least 5 days.

I have recovered from recent surgery for my recurring condition and it's been over 28 days since the operation.

See 9 more

Exclusion Criteria

You have a ventricular shunt or catheter.

You have something inside your head, like a piece of a bullet.

I have a brain tumor below the tentorium, possibly with another growing above it.

See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Optune device in monotherapy for ≥ 18 hours per day, with monthly visits for toxicity assessment and compliance evaluation

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for overall survival and safety

2 years

Treatment Details

Interventions

Optune (NovoTTF-100A)

Trial Overview The trial is testing the Optune device to see if it helps control tumor growth in patients with specific types of brain tumors that haven't responded well to standard treatments. Optune is experimental for this use but approved for another type of brain cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Optune (NovoTTF-100A)Experimental Treatment1 Intervention

The treatment plan is to have patients use the Optune device in monotherapy for ≥ 18 hours per day as per the treatment standard established from prior studies. A medical professional will see each patient at least once per month while on the device for toxicity assessment, compliance evaluation via downloading of the log-file on the device by the Novocure technician (which involves the technician simply attaching the device to a computer via USB where software reads how many hours per day on each day the device was used), and physical examination. Extent of disease evaluations will occur at baseline, 8 weeks, and then every 8 weeks thereafter. These evaluations will include MRI of the brain with and without contrast and perfusion (or CT head if a patient cannot undergo MRI).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

NovoCure Ltd.

Industry Sponsor

Trials

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

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Findings from Research

In the phase II CEVOREM trial involving 20 patients with recurrent aggressive meningiomas, the combination of everolimus and octreotide resulted in a 55% progression-free survival rate at 6 months, indicating significant efficacy for this treatment approach.

The treatment led to a major decrease in tumor growth rate, with 78% of tumors showing over a 50% reduction in growth at 3 months, suggesting that this combination therapy could effectively slow tumor progression in aggressive meningiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus and Octreotide for Patients with Recurrent Meningioma: Results from the Phase II CEVOREM Trial.Graillon, T., Sanson, M., Campello, C., et al.[2021]

In a study involving 63 freshly operated meningiomas, the combination of the Pi3k inhibitor alpelisib and the MEK inhibitor trametinib showed a greater inhibitory effect on tumor cell viability and proliferation compared to everolimus, regardless of tumor grade or genomic status.

The combined treatment effectively reversed AKT activation induced by trametinib and provided an additive anti-proliferative effect, suggesting that co-targeting the Pi3k-AKT-mTOR and MAP kinase pathways could be a promising strategy for treating aggressive meningiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-Targeting MAP Kinase and Pi3K-Akt-mTOR Pathways in Meningioma: Preclinical Study of Alpelisib and Trametinib.Mondielli, G., Mougel, G., Darriet, F., et al.[2022]

Recent advances in understanding meningioma biology have identified new therapeutic targets, including the mTOR and Pi3K-Akt pathways, which are currently being explored in clinical trials for treating aggressive meningiomas.

Despite the discovery of potential targets and the use of therapies like Anti-VEGF and mTOR inhibitors, the treatment of high-grade meningiomas remains challenging, with limited efficacy from current options and a need for innovative approaches such as immunotherapy and targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative treatments for meningiomas.Graillon, T., Tabouret, E., Salgues, B., et al.[2023]