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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
| Columbia University | OTHER |
| University of Cincinnati | OTHER |
| University of Colorado, Denver |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optune (NovoTTF-100A) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From the treatment start date to date of death of any cause. | 2 year |
| safety and tolerability | graded according to most up-to-date CTCAE version |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kaley, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | United States | |||
| University of Colorado |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| University of Miami | OTHER |
| Cedars-Sinai Medical Center | OTHER |
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| 2 years |
| Denver |
| Colorado |
| United States |
| University of Miami | Miami | Florida | United States |
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States |
| Memorial Sloan Kettering Cancer Center at Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering West Harrison | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Columbia University | New York | New York | United States |
| University of Cincinnati | Cincinnati | Ohio | United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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