Optune Device for Meningioma

Not currently 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Optune device to assess its effects on patients with meningioma, particularly when surgery and radiation have not succeeded. The Optune device, a wearable device that delivers tumor-treating fields, has approval for another type of brain tumor but remains experimental for meningioma. Participants will use the device daily to determine if it helps control tumor growth. The trial seeks individuals whose meningioma has recurred after treatment and who have undergone prior radiotherapy. As an unphased trial, it offers patients a chance to explore a potentially effective treatment option when other methods have failed.

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.

What prior data suggests that the Optune device is safe for meningioma patients?

Research has shown that the Optune device, though not yet approved for treating meningioma, has been used for another type of brain tumor, providing some safety information. In other studies where Optune was used, most side effects were mild to moderate. The most common issues were skin-related, such as rashes or irritation at the device placement site, and no severe or unexpected toxic effects were reported.

Previous findings suggest that the device is generally well-tolerated, with no unexpected serious side effects. This offers some reassurance about its safety, but it's important to remember that each person's experience can differ. Participants in the study will have regular check-ups to monitor for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for meningioma, which typically involve surgery and radiation, the Optune device offers a non-invasive approach by using electric fields to disrupt cancer cell division. This innovative method targets tumor cells specifically, minimizing damage to surrounding healthy tissue. Researchers are excited about Optune because it can be used continuously for most of the day, potentially enhancing its effectiveness without the side effects associated with chemotherapy or radiation.

What evidence suggests that the Optune device is effective for meningioma?

Research has shown that the Optune device, also known as NovoTTF-100A, might help shrink meningioma tumors. In one study, brain scans revealed that tumors could shrink by up to 60% over several weeks. The device uses electric fields to stop tumors from growing and potentially make them smaller. Although approved for treating other brain tumors, it is still under testing for meningioma in this trial. Early results are promising, suggesting that the device may work for some patients. ^{3 5 6 7 8}

Who Is on the Research Team?

Thomas Kaley, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Optune (NovoTTF-100A) Experimental Treatment 1 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).

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

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

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Published Research Related to This Trial

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]

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]

Citations

1.

clinicaltrial.be

clinicaltrial.be/en/details/12311?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypic...

The purpose of this study is to find out what effects, good or bad, the Optune device has on the patient and meningioma.

2.

academic.oup.com

academic.oup.com/neuro-oncology/article/18/suppl_6/vi11/2541871

ACTR-43. PILOT STUDY OF OPTUNE (NOVOTTF-100A) FOR ...

RESULTS: To date, 6 patients (3 female) with a median age of 60.4 years (range 27.5–70.2 years) and median KPS of 70 (range 60–100%) have been ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7651609/

NCOG-52. TUMOR TREATING FIELDS IN MENINGIOMA

Brain MRI scans 8, 16 and 20 weeks later showed a reduction in the meningioma tumor size of 42%, 58% & 60%, respectively. Currently, two ongoing trials test the ...

4.

clinconnect.io

clinconnect.io/trials/NCT01892397

Pilot Study of Optune (NovoTTF-100A) for Recurrent

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02847559

NCT02847559 | Optune Delivered Electric Field Therapy ...

It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by ...

6.

withpower.com

withpower.com/trial/phase-meningioma-5-2013-37dad

Optune Device for Meningioma · Info for Participants

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

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf10/p100034b.pdf

FDA - summary of safety and effectiveness data (sSED)

The clinical study that formed the basis for determining that the NovoTTF- IOOA. System is safe and effective for its intended use was a multicenter, randomized ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9443515/

Safety of Tumor Treating Fields (TTFields) therapy in pediatric ...

Data presented here suggest a favorable safety profile for TTFields therapy, with predominantly mild to moderate localized skin AEs and no unexpected toxicities ...