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

NCT02847559 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Priya Kumthekar, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02847559 on ClinicalTrials.gov