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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Given IV
Undergo electric field therapy using Optune device
Undergo electric field therapy using Optune device
Ancillary studies
John Wayne Cancer Center at Providence St. John's Health Center
Santa Monica, California, United States
COMPLETEDMiami Cancer Institute
Miami, Florida, United States
COMPLETEDPiedmont Healthcare
Atlanta, Georgia, United States
COMPLETEDNorthwestern University
Chicago, Illinois, United States
RECRUITINGNorthwestern University- Lake Forest Hospital
Lake Forest, Illinois, United States
ACTIVE_NOT_RECRUITINGNorthwestern Medicine/ Cadence Health - CDH
Winfield, Illinois, United States
RECRUITINGVidant Medical Center, East Caroling University
Greenville, North Carolina, United States
ACTIVE_NOT_RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGProgression 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
Overall Survival (OS)
OS will be defined from the time of registration to death and will be assessed for up to 2 years.
Time frame: From time of registration to death, assessed up to 2 years
Tumor Response Rate (TRR)
Imaging (MRI or CT scan) will assess radiographic response in terms of complete response, partial response, stable disease, and progressive disease. The iRANO criteria will be used for response assessment.
Time frame: At baseline and every eight weeks, assessed up to 12 months
Quality of Life (QOL) with treatment using FACT-Br questionnaire
To assess QOL with treatment the Functional Assessment of Cancer Therapy-Brain version 4.0 (FACT-Br) questionnaire will be administered.
Time frame: At baseline, on Day 1 of every cycle, and 1 month after the last dose of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.