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Anti-angiogenic agent

Electric Field Therapy + Bevacizumab for Meningioma

Phase 2

Recruiting

Led By Priya Kumthekar, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient's tumor must have a supratentorial component

All patients must have developed recurrent disease/progression after receiving all standard treatments including surgical resection, if possible, and definitive radiation therapy for unresectable or recurrent meningioma

Must not have

Patients with infratentorial disease and spinal disease

Previous treatment with bevacizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of registration to death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the addition of bevacizumab to Optune improves meningioma control.

Who is the study for?

This trial is for adults with Grade 2 or 3 meningioma that has come back or gotten worse after standard treatments, including surgery and radiation. They must have a life expectancy of at least 12 weeks, be able to perform daily activities (Karnofsky performance status >=60%), and have good organ function. Women who can get pregnant and men with partners who can get pregnant must use birth control. People can't join if they've had recent surgeries, are on certain other treatments, have specific medical devices implanted, are sensitive to hydrogels, have uncontrolled blood pressure or bleeding disorders, or are pregnant/nursing.

What is being tested?

The study tests the combination of Bevacizumab (a drug blocking new blood vessel growth) and Optune (a device delivering electric fields to the brain) in treating recurrent/progressive meningiomas. Bevacizumab isn't FDA-approved for this cancer type yet; it aims to starve tumors by cutting off their blood supply. Optune is worn daily for at least 18 hours and disrupts tumor cell division.

What are the potential side effects?

Bevacizumab may cause issues like high blood pressure, bleeding problems, wounds not healing properly, protein in urine indicating kidney damage among others. The Optune device might lead to skin irritation under where it's placed and could potentially interfere with other electronic medical devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is located in the upper part of my brain.

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My meningioma has returned or worsened after all standard treatments.

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I can care for myself but may need occasional help.

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My meningioma is classified as grade 2 or 3.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer affects the lower part of my brain or spine.

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I have been treated with bevacizumab before.

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I have a serious wound or bone fracture that is not healing.

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I have a bleeding disorder or significant blood clotting issues.

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I am on long-term medication to suppress my immune system.

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I have severe health conditions that are not under control.

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My high blood pressure is not well controlled.

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I haven't taken any experimental drugs or cancer treatments in the last 28 days.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of registration to death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of registration to death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of registration to death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival for 6 months (PFS-6)

Secondary study objectives

Overall Survival (OS)

Quality of Life (QOL) with treatment using FACT-Br questionnaire

Tumor Response Rate (TRR)

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bevacizumab, electric field therapy)Experimental Treatment4 Interventions

Patients receive bevacizumab 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NovoTTF-200A Device

2018

Completed Early Phase 1

~30

Quality-of-Life Assessment

2017

Completed Phase 3

~4910