Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma (NCT01892397) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
United States6 participantsStarted 2013-06
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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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 prio…