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.
Patients must have a histologic diagnosis of meningioma, World Health Organization (WHO) grade 2 or 3 (atypical or anaplastic)
Patient's tumor must have a supratentorial component
Patients must have measurable or non-measurable (evaluable) disease recurrence; recurrence must be documented by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Surgical resection, if possible;
Patients who have had major surgery or significant traumatic injury within 4 weeks prior to registration, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study
Patients who have had minor surgical procedures (with the exception of the placement of porta cath or other central venous access) within 7 days prior to registration
Patients with infratentorial disease and spinal disease
Patients may not be receiving any other investigational agents; (i.e. 28-day washout period from prior investigational drug is required)
Single group
Bevacizumab
Biological/VaccineGiven IV
Electric Field Therapy
Procedure/SurgeryUndergo electric field therapy using Optune device
NovoTTF-200A Device
DeviceUndergo electric field therapy using Optune device
Quality-of-Life Assessment
Procedure/SurgeryAncillary studies
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
Overall Survival (OS)
OS will be defined from the time of registration to death and will be assessed for 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.
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.
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Northwestern University
Lead sponsor
NovoCure Ltd.
Collaborator
National Cancer Institute (NCI)
Collaborator
