Electric field device tested for Hard-to-Treat brain tumor
NCT ID NCT01892397
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This pilot study tests an experimental device called Optune in people with recurrent atypical or anaplastic meningioma, a type of brain cancer that has come back after surgery or radiation. The device delivers electric fields to the tumor area to try to stop cancer cells from growing. The study aims to see if Optune can improve progression-free survival and overall survival, and whether it is safe and tolerable for these patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Optune (NovoTTF-100A) device
- What this could lead to
- If effective, Optune could offer a new treatment option for patients with recurrent meningioma that has not responded to surgery or radiation.
- What could go wrong
- This is a very small pilot study with only 6 participants, so results may not apply broadly. The device is experimental for this tumor type and may not slow tumor growth or improve survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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6 people
The number who actually took part.
- Started
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Jun 2013
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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). * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
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Columbia University
New York, New York, United States
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
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University of Cincinnati
Cincinnati, Ohio, United States
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University of Colorado
Denver, Colorado, United States
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University of Miami
Miami, Florida, United States
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