Optune Device for Meningioma
Trial Summary
Do I need to stop my current medications for the Optune Device trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not be using any other investigational drugs or be part of another treatment trial.
Is the Optune device generally safe for humans?
How does the Optune treatment differ from other treatments for meningioma?
The Optune device is unique because it uses electric fields to disrupt cancer cell division, which is different from traditional treatments like surgery or radiation that physically remove or target the tumor. This non-invasive approach offers an alternative for patients who may not be candidates for surgery or have tumors that are resistant to other treatments.16789
What is the purpose of this trial?
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.
Research Team
Thomas Kaley, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Optune device in monotherapy for ≥ 18 hours per day, with monthly visits for toxicity assessment and compliance evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and safety
Treatment Details
Interventions
- Optune (NovoTTF-100A)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Columbia University
Collaborator
University of Colorado, Denver
Collaborator
Cedars-Sinai Medical Center
Collaborator
University of Miami
Collaborator
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution
University of Cincinnati
Collaborator