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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
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 belowSelect...
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:Select...
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
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
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).
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,550 Total Patients Enrolled
Columbia UniversityOTHER
1,471 Previous Clinical Trials
2,536,344 Total Patients Enrolled
University of Colorado, DenverOTHER
1,786 Previous Clinical Trials
2,787,602 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.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.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or cervical carcinoma in-situ.I have symptoms or signs of high pressure inside my skull.Patients must have a tumor or abnormal tissue that can be measured to be at least 1cm x 1cm on a medical scan.I am not pregnant or breastfeeding and agree to use effective birth control.I am currently suffering from a severe infection.I have a part of my skull missing.I have had radiation for meningioma and my tumor has grown since then.I have had any number of surgeries, radiation, or chemotherapy treatments.My brain tumor is a grade II or III meningioma.I can care for myself but may need occasional help.It has been at least 4 weeks since my last cancer treatment.I have NF and any brain tumors I have haven't grown in the last 6 months.Your blood takes longer to clot than normal.I am not on any other clinical trials except for those focused on supportive care or quality of life.You have very low platelet or neutrophil counts in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Optune (NovoTTF-100A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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