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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of registration to death, assessed up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My tumor is located in the upper part of my brain.
Select...
My meningioma has returned or worsened after all standard treatments.
Select...
I can care for myself but may need occasional help.
Select...
My meningioma is classified as grade 2 or 3.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival for 6 months (PFS-6)
Secondary outcome measures
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 • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
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
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
NovoTTF-200A Device
2018
Completed Early Phase 1
~30
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,204 Total Patients Enrolled
3 Trials studying Meningioma
109 Patients Enrolled for Meningioma
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,695 Total Patients Enrolled
1 Trials studying Meningioma
6 Patients Enrolled for Meningioma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,654 Total Patients Enrolled
45 Trials studying Meningioma
4,210 Patients Enrolled for Meningioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 12 more weeks.My cancer affects the lower part of my brain or spine.I have been treated with bevacizumab before.I have not had a stroke or mini-stroke in the last 6 months.If you are capable of becoming pregnant, you need to have a recent negative pregnancy test before joining the study.I have a serious wound or bone fracture that is not healing.I have a bleeding disorder or significant blood clotting issues.I am on long-term medication to suppress my immune system.My tumor is located in the upper part of my brain.My meningioma has returned or worsened after all standard treatments.I have not taken bevacizumab, but may have had other treatments for my condition, with a 4-week break before joining this trial.My bone marrow, kidney, and liver are functioning well.I agree to use effective birth control during the study.I have not coughed up or vomited blood in the last 28 days.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.I have severe health conditions that are not under control.My high blood pressure is not well controlled.You must have evidence of disease recurrence shown on an MRI or CT scan.I have not had major surgery or significant injury in the last 4 weeks.You have had protein in your urine within the past 14 days.You have a known allergy to conductive hydrogels.I have not had a heart attack or unstable chest pain in the last 6 months.I had a minor surgery less than a week ago.I can understand and am willing to sign the consent form.I can care for myself but may need occasional help.I haven't taken any experimental drugs or cancer treatments in the last 28 days.My meningioma is classified as grade 2 or 3.I am not pregnant or nursing.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (bevacizumab, electric field therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please describe the potential risks associated with Bevacizumab?
"Bevacizumab's safety is based on Phase 2 data, so it received a score of 2."
Answered by AI
Do you have any openings for new participants in this clinical trial?
"The most up-to-date information on clinicaltrials.gov suggests that this study is still recruiting patients. This trial was initially posted on August 1st, 2016 and received its latest edit on May 25th, 2022."
Answered by AI
How many people are enrolled in this experiment?
"Per the requirements of this clinical trial, 27 patients that meet specific inclusion criteria must take part. These patients can choose to participate at Piedmont Healthcare in Atlanta, Georgia or John Wayne Cancer Center at Providence St. John's Health Center in Santa Monica, California (among other locations)."
Answered by AI
What is the most common application for Bevacizumab?
"Bevacizumab is an effective treatment for various cancers, such as malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and stage iv epithelial ovarian cancer."
Answered by AI
What is the saturation of hospitals running this research project in metropolitan areas?
"Presently, there are 8 sites enrolling patients for this clinical trial. The locations of these centres include Atlanta, Santa Monica and Winfield amongst others. If you enroll in the trial, it is beneficial to choose a location near you to reduce travel costs and time."
Answered by AI
Could you tell me about other tests that have included Bevacizumab?
"As of right now, there are 375 active clinical trials involving Bevacizumab. Out of those, 99 are in Phase 3. Most of these studies originate from Taibei, Taiwan; however, there are a total of 18908 locations running trials for Bevacizumab around the world."
Answered by AI
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