NCT02847559 · Northwestern University
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
What this study is about
The purpose of this research study is to determine the effects bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Bevacizumab is considered experimental because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas.
View original scientific description
The purpose of this research study is to determine the effects bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Bevacizumab is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels.
Interventions
BIOLOGICAL
Bevacizumab
Given IV
PROCEDURE
Electric Field Therapy
Undergo electric field therapy using Optune device
DEVICE
NovoTTF-200A Device
Undergo electric field therapy using Optune device
PROCEDURE
Quality-of-Life Assessment
Ancillary studies
Primary outcome measures
Progression Free Survival for 6 months (PFS-6)
Time frame: At 6 months
Determine the efficacy of combination therapy of bevacizumab and Optune (TTF) as assessed by Progression Free Survival at 6 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have a histologic diagnosis of meningioma, World Health Organization (WHO) grade 2 or 3 (atypical or anaplastic)
- Patient's tumor must have a supratentorial component
- Patients must have measurable or non-measurable (evaluable) disease recurrence; recurrence must be documented by magnetic resonance imaging (MRI) or computed tomography (CT) scan
- All patients must have developed recurrent disease/progression (evidence of recurrence to be established by MRI or CT scan with contrast; there is no limit to the number of relapses) after receiving all standard treatments, which must include the following:
- Surgical resection, if possible;
- Definitive radiation therapy for unresectable meningioma, or for recurrent meningioma after resection (Note: At registration, patients must be at least 28 days post-surgery, and must be at least 28 days post-radiation therapy, with resolution of related cytotoxicities down to grade 2)
- Patients may have had pr
Where
- Santa Monica, California
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Lake Forest, Illinois
- Winfield, Illinois
- Greenville, North Carolina
- Philadelphia, Pennsylvania
Collaborators
NovoCure Ltd., National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 27, 2025 · Source of record for eligibility and locations