NCT02847559

Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma

A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in the Setting of Recurrent or Progressive Meningioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaplastic (Malignant) Meningioma
• Atypical Meningioma
• Grade II Meningioma
• Grade III Meningioma
• Recurrent Meningioma
• Supratentorial Meningioma

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
PROCEDURE	Electric Field Therapy	Undergo electric field therapy using Optune device
DEVICE	NovoTTF-200A Device	Undergo electric field therapy using Optune device
PROCEDURE	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-08-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2016-07-28
• Last updated: 2025-06-27

Locations

8 sites across 1 country: United States