RecruitingPhase 2NCT02847559

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


Sponsor

Northwestern University

Enrollment

27 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Bevacizumab, a procedure called Electric Field Therapy, and others for people with anaplastic (malignant) meningioma, atypical meningioma, and other related conditions. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(8)

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

View Full Details on ClinicalTrials.gov

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NCT02847559


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