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. TTo determine the efficacy of Optune (TTF) therapy with Bevacizumab as assessed by Progression Free Survival (PFS) at 6 months (PFS-6) in patients with recurrent or progressive meningioma. PFS-6 will be defined from the time of registration to the time of confirmed progression. In cases where this might be unclear, patients may continue on trial and if progression is confirmed later, then the original date where first changes occurred will be used. SECONDARY OBJECTIVES: I. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab. II. To determine overall survival (OS). III. To determine tumor response rate (TRR). IV. To determine Objective Response Rate (ORR) V. To assess quality of life with treatment (QOL) using FACT-Br questionnaire. OUTLINE: This is a trial of Optune with concurrent standard of care treatment bevacizumab. Both treatments can start simultaneously with either starting first, but both must start within a window of 1 week. 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 for at least18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are responding will remain on study treatment for 6 months.After 6 months, patients may still continue on OPTUNE and Bevacizumab at the discretion of their treating physician. NOTE:At any point, if patients discontinue bevacizumab secondary to side effects, then they may continue Optune alone per treating physician's discretion. 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
20
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
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
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. PFS-6 will be defined from the time of registration to the time of confirmed progression. In cases where this might be unclear, patients may continue on trial and if progression is confirmed later, then the original date where first changes occurred will be used.
Time frame: At 6 months
To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab.
To collect the safety and tolerability data for Optune (TTF) in combination with bevacizumab, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to Optune and bevacizumab, according the NCI-CTCAE version 4.03.
Time frame: All subjects who receive at least 1 dose of bevacizumab and use the Optune device for at least 1 day will be evaluable for this endpoint. AEs are followed from treatment initiation through 30 days after the last dose.
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. TRR will be assessed in terms of: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).
Time frame: At baseline and every eight weeks, assessed up to 12 months
To determine Objective Response Rate (ORR)
ORR will be measured via Brain MRI (or CT with contrast if contraindicated). ORR will beassessed in terms of: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).
Time frame: Imaging studies will be performed at baseline, during week eight (prior to cycle 3), and every eight weeks thereafter (prior to odd number cycles).
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
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