Brain CancerNCT01892397
Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
A study testing Optune (NovoTTF-100A) in people with Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Optune (NovoTTF-100A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2013to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
- Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery.
- Patients must have measurable disease, defined as at least 1cm x 1 cm of contrast enhancing disease.
- Patients must have received prior radiotherapy for meningioma. Patients may have received standard external beam radiation, interstitial brachytherapy, or radiosurgery in any combination. An interval of > 4 weeks (28 days) must have elapsed from the completion of radiotherapy to study entry and there must be subsequent evidence of tumor progression. Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR-perfusion, MR-spectroscopy, or surgical documentation of disease. If there is any question, investigators should discuss with the MSKCC PI.
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- Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy.
- All patients must be able to provide informed consent indicating that they are aware of the investigational nature of the study. Patients must provide an authorization for the release of their protected health information.
- Age > or = to 18 years old
- Karnofsky performance status > or = to 60%
- 4 weeks (28 days) from any radiation treatment, stereotactic radiosurgery, conventional surgery, or chemotherapy.
- Life expectancy at least 3 months
- Patients with NF (Neurofibromatosis) are eligible, and may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months.
Who cannot join
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years).
- Concomitant use of any other investigational drugs.
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials (i.e. Quality of life) are allowed.
- Pregnancy or breast feeding. Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to effective contraception. Female patients of child bearing potential (ages 11-55) must have a negative B-HCG pregnancy test documented within 14 days prior to registration.
- Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator.
- Evidence of increased intracranial pressure (midline shift >5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).
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- Infratentorial meningioma (patients may have infratentorial meningioma if there is concurrent growing supratentorial meningioma that serves as the target lesion)
- Coagulopathy (as evidenced by PT or APTT >1.5 times upper limit of normal in patients not undergoing anticoagulation)
- Thrombocytopenia (platelet count <100x10^3/uL) Neutropenia (absolute neutrophil count <1x10^3/uL)
- Severe acute infection
- Skull defect with missing bone
- Ventricular shunt/catheter
- Presence of a foreign body intracranially such as a bullet fragment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
University of Cincinnati
Cincinnati, Ohio
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725
University of Colorado
Denver, Colorado
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Cedars-Sinai Medical Center
Los Angeles, California
University of Miami
Miami, Florida
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Columbia University
New York, New York
About this study
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.
- Conditions
- Brain Cancer
- Being tested
- Optune (NovoTTF-100A)
- Keywords
- intracranial supratentorial meningioma, Atypical and Anaplastic Meningioma, Optune (NovoTTF-100A), 13-067
- Medical subject headings
- Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optune (NovoTTF-100A)Device
| Study group | Role | What they receive |
|---|---|---|
| Optune (NovoTTF-100A) | Experimental | 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). Receives: Device: Optune (NovoTTF-100A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival rate
From the treatment start date to the date of the first observation of progressive disease (including clinical progression) or death due to any cause. Patients not known to be progression-free at 6 months will be considered treatment failures.
Measured: 6 months
Secondary outcomes (2)
overall survival
From the treatment start date to date of death of any cause.
Measured: 2 year
safety and tolerability
graded according to most up-to-date CTCAE version
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd., Columbia University, University of Cincinnati, University of Colorado, Denver, University of Miami, Cedars-Sinai Medical Center
- Responsible party
- Sponsor
- Investigators
- Thomas Kaley, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892397
- Sponsor's protocol ID
- 13-067
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2013
- Last updated
- 6 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
- ClinicalTrials.gov ID
- NCT01892397
- Acronym / sponsor ID
- 13-067
- Conditions
- Brain Cancer
- Keywords
- intracranial supratentorial meningioma, Atypical and Anaplastic Meningioma, Optune (NovoTTF-100A), 13-067
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- NovoCure Ltd., Columbia University, University of Cincinnati, University of Colorado, Denver, University of Miami, Cedars-Sinai Medical Center
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optune (NovoTTF-100A) | Experimental | Device: Optune (NovoTTF-100A)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
- Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery.
- Patients must have measurable disease, defined as at least 1cm x 1 cm of contrast enhancing disease.
Key exclusion criteria (13 listed)
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years).
- Concomitant use of any other investigational drugs.
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials (i.e. Quality of life) are allowed.
- Pregnancy or breast feeding. Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to effective contraception. Female patients of child bearing potential (ages 11-55) must have a negative B-HCG pregnancy test documented within 14 days prior to registration.
- Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optune (NovoTTF-100A) | Device | Optune (NovoTTF-100A) |
Primary outcome
progression-free survival rate
Time frame: 6 months
From the treatment start date to the date of the first observation of progressive disease (including clinical progression) or death due to any cause. Patients not known to be progression-free at 6 months will be considered treatment failures.
2 secondary outcomes
overall survival
Time frame: 2 year
safety and tolerability
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kaley, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optune (NovoTTF-100A) in people with Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.