Actively Recruiting
A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in Recurrent or Progressive Grade 2 or 3 Meningioma
Led by Northwestern University ยท Updated on 2025-06-27
27
Participants Needed
8
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
NovoCure Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study evaluates the effects of combining bevacizumab, an investigational drug that blocks new blood vessel growth, with Optune, an investigational device delivering electric field therapy, on patients with recurrent or progressive grade 2 or 3 meningiomas. The study aims to determine progression-free survival at 6 months and assess overall survival, tumor response, and quality of life in these patients. The research addresses a need for new treatment options for meningiomas that have returned or worsened after standard therapies. Participants receive bevacizumab intravenously on days 1 and 15 of the first four 28-day treatment courses. From course 5 onward, patients may choose to continue bevacizumab every 2 or 3 weeks. They also use the Optune device daily for at least 18 hours, which delivers electrical currents to slow tumor growth by disrupting cell division. Treatment continues in repeated cycles until the disease progresses or unacceptable side effects occur. After treatment ends, patients are followed every 3 months for up to 2 years. During the study, participants undergo regular MRI or CT scans to document tumor recurrence, and their quality of life is assessed using a questionnaire. Safety is monitored through laboratory tests evaluating blood counts and organ function. The main measure is progression-free survival at 6 months, with secondary measures including overall survival, tumor response rate, and quality of life. The study involves ongoing monitoring to track treatment effects and patient well-being during and after the therapy period.
CONDITIONS
Brief 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 grade 2 or 3 meningioma (atypical or anaplastic)
- Tumor must have a supratentorial component
- Measurable or evaluable disease recurrence documented by MRI or CT scan
- Recurrent disease after all standard treatments including surgery and radiation
- At least 28 days post-surgery and radiation with resolution of related toxicities to grade 2 or less
- No prior bevacizumab treatment; 4 week wash-out for other systemic therapies
- Life expectancy of at least 12 weeks
- Karnofsky performance status of 60% or higher
- Adequate bone marrow, kidney, and liver function within 14 days before registration
- Use of adequate contraception for females of child-bearing potential and males with partners of child-bearing potential
- Negative pregnancy test for females of child-bearing potential within 14 days prior to registration
- Ability and willingness to sign informed consent and comply with study requirements
You will not qualify if you...
- Major surgery or significant injury within 4 weeks prior to registration or not recovered from prior surgery
- Minor surgery within 7 days prior to registration, except central venous access placement
- Infratentorial or spinal disease
- Receiving other investigational agents or anti-cancer therapies within 28 days prior to registration
- Prior treatment with bevacizumab
- Allergic reactions to bevacizumab or similar compounds
- Active implanted medical devices, skull defects, shunts, or bullet fragments
- Sensitivity to conductive hydrogels used in electrodes
- Proteinuria exceeding study limits
- Serious non-healing wounds, active ulcers, or untreated bone fractures
- Bleeding disorders or recent significant bleeding episodes
- Recent myocardial infarction, unstable angina, stroke, or hypertensive crisis
- Inadequately controlled hypertension
- Chronic systemic immunosuppressive treatment except stable corticosteroids for cerebral edema
- Severe or uncontrolled medical conditions that may interfere with study participation
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive bevacizumab intravenously on days 1 and 15 of the first four 28-day courses, then may continue bevacizumab every 2 or 3 weeks starting course 5. They also undergo daily electric field therapy using the Optune device for about 18 hours each day during treatment courses. Treatment continues in repeating 28-day cycles until disease progression or unacceptable side effects occur.
Visits on days 1 and 15 of courses 1-4, then every 2 or 3 weeks starting course 5
Duration - Up to 2 years
After completing study treatment, participants are followed up every 3 months for up to 2 years to monitor overall survival and health status.
Follow-up visits every 3 months
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
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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