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Device

Optune Device for Meningioma

N/A

Waitlist Available

Led By Thomas Kaley, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven recurrent WHO grade II (atypical) or grade III (anaplastic) intracranial supratentorial meningioma. MSKCC central review of histology is not required.

Unequivocal evidence for tumor progression by MRI with and without contrast and with perfusion (or CT scan is MRI with contraindicated). The scan must be performed within 14 days of registration.

Must not have

Evidence of increased intracranial pressure (midline shift >5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).

Severe acute infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called Optune to see if it's effective in treating meningiomas. The device is experimental and has not been approved by the FDA.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here as Optune is a device rather than a drug; however, similar devices may cause skin irritation where applied, headaches, malaise or local discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is a grade II or III meningioma.

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My recent scans show my tumor is growing.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms or signs of high pressure inside my skull.

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I am currently suffering from a severe infection.

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I have a part of my skull missing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression-free survival rate

Secondary study objectives

overall survival

safety and tolerability

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: 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).

0 / 7Eligibility criteria met