A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in the Setting of Recurrent or Progressive Meningioma
Summary
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.
Detailed description
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.
Arms & interventions
- BiologicalBevacizumab
Given IV
- ProcedureElectric Field Therapy
Undergo electric field therapy using Optune device
- DeviceNovoTTF-200A Device
Undergo electric field therapy using Optune device
- ProcedureQuality-of-Life Assessment
Ancillary studies
Outcome measures
Primary
Progression Free Survival for 6 months (PFS-6)
Determine the efficacy of combination therapy of bevacizumab and Optune (TTF) as assessed by Progression Free Survival at 6 months
Time frame: At 6 months
Secondary
Overall Survival (OS)
Time frame: From time of registration to death, assessed up to 2 years
Tumor Response Rate (TRR)
Time frame: At baseline and every eight weeks, assessed up to 12 months
Quality of Life (QOL) with treatment using FACT-Br questionnaire
Time frame: At baseline, on Day 1 of every cycle, and 1 month after the last dose of study drug
Eligibility criteria
Study locations (8)
John Wayne Cancer Center at Providence St. John's Health Center
Santa Monica, California, 90404
Miami Cancer Institute
Miami, Florida, 33176
Piedmont Healthcare
Atlanta, Georgia, 30309
Northwestern University
Chicago, Illinois, 60611
Northwestern University- Lake Forest Hospital
Lake Forest, Illinois, 60045
Northwestern Medicine/ Cadence Health - CDH
Winfield, Illinois, 60190
Vidant Medical Center, East Caroling University
Greenville, North Carolina, 27834
University of Pennsylvania
Philadelphia, Pennsylvania, 19104