Actively Recruiting
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
Led by Northwestern University · Updated on 2025-06-27
27
Participants Needed
8
Research Sites
539 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
NovoCure Ltd.
Collaborating Sponsor
AI-Summary
What this Trial 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 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. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune is also considered investigational because the US FDA has not approved its use for the treatment of meningiomas. Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient's brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed.
CONDITIONS
Official Title
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of WHO Grade 2 or 3 meningioma (atypical or anaplastic)
- Tumor must have a supratentorial component
- Measurable or evaluable disease recurrence confirmed by MRI or CT scan
- Recurrent disease or progression after all standard treatments including surgery and radiation
- At least 28 days post-surgery and 28 days post-radiation with resolved related toxicities to grade 2 or less
- No prior treatment with bevacizumab; 4 week washout required for other systemic treatments
- Life expectancy of at least 12 weeks
- Karnofsky performance status of 60% or higher
- Adequate bone marrow, kidney, and liver function within 14 days prior to registration
- Females of child-bearing potential and males with partners of child-bearing potential must agree to use contraception
- Negative pregnancy test within 14 days prior to registration for females of child-bearing potential
- Ability to understand and willingness to sign informed consent
- Ability to comply with all protocol requirements
You will not qualify if you...
- Major surgery or significant injury within 4 weeks prior to registration or not recovered from such surgery
- Minor surgical procedures within 7 days prior to registration (except central venous access placement)
- Presence of infratentorial or spinal disease
- Receiving other investigational agents or anti-cancer therapies within 28 days prior to registration
- Prior treatment with bevacizumab
- History of allergic reactions to bevacizumab or similar compounds
- Active implanted medical device, skull defect without replacement, shunt, or bullet fragments
- Sensitivity to conductive hydrogels used in electrodes
- Proteinuria above specified limits within 14 days of registration
- Serious non-healing wounds, active ulcers, or untreated bone fractures
- Evidence of bleeding disorders or significant coagulopathy without anticoagulation
- Recent hematemesis or hemoptysis within 28 days prior to registration
- History of myocardial infarction or unstable angina within 6 months
- Uncontrolled hypertension above specified blood pressure levels
- History of stroke or transient ischemic attack within 6 months
- Prior hypertensive crisis or hypertensive encephalopathy
- History of abdominal fistula or gastrointestinal perforation within 6 months
- Chronic systemic immunosuppressive treatment except stable corticosteroids for cerebral edema
- Severe or uncontrolled medical conditions that could interfere with study compliance or safety
- Pregnant or nursing female patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
John Wayne Cancer Center at Providence St. John's Health Center
Santa Monica, California, United States, 90404
Completed
2
Miami Cancer Institute
Miami, Florida, United States, 33176
Completed
3
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Completed
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Northwestern University- Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Active, Not Recruiting
6
Northwestern Medicine/ Cadence Health - CDH
Winfield, Illinois, United States, 60190
Actively Recruiting
7
Vidant Medical Center, East Caroling University
Greenville, North Carolina, United States, 27834
Active, Not Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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