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A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in the Setting of Recurrent or Progressive Meningioma
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.
PRIMARY OBJECTIVES: I. To determine progression free survival (PFS) for 6 months (PFS-6) in patients with recurrent or progressive meningioma. SECONDARY OBJECTIVES: I. To determine overall survival (OS). II. To determine tumor response rate (TRR). III. To assess quality of life with treatment (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. OUTLINE: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 of courses 1-4. Beginning on day 1 of course 5, patients may choose to receive bevacizumab IV every 3 weeks or remain on the every 2-week schedule. Patients also undergo electric field therapy using Optune (formerly NovoTTF-200A System) daily over 18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
John Wayne Cancer Center at Providence St. John's Health Center
Santa Monica, California, United States
Miami Cancer Institute
Miami, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northwestern University- Lake Forest Hospital
Lake Forest, Illinois, United States
Northwestern Medicine/ Cadence Health - CDH
Winfield, Illinois, United States
Vidant Medical Center, East Caroling University
Greenville, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
August 1, 2016
Primary Completion Date
September 1, 2026
Completion Date
December 1, 2026
Last Updated
June 27, 2025
27
ESTIMATED participants
Bevacizumab
BIOLOGICAL
Electric Field Therapy
PROCEDURE
NovoTTF-200A Device
DEVICE
Quality-of-Life Assessment
PROCEDURE
Lead Sponsor
Northwestern University
Collaborators
NCT00045110
NCT02194452
Data Source & Attribution
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