Electric Field Therapy + Bevacizumab for Meningioma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires a 4-week period without taking any systemic treatments before joining. You cannot take other investigational drugs or anti-cancer therapies during the trial.
What data supports the effectiveness of the drug Bevacizumab for treating meningioma?
Research suggests that Bevacizumab, which blocks a protein that helps tumors grow blood vessels, may help shrink meningiomas (a type of brain tumor) and reduce swelling around them, especially in more aggressive cases. This is based on findings from studies on patients with difficult-to-treat meningiomas.12345
Is Electric Field Therapy + Bevacizumab safe for treating meningioma?
Bevacizumab, used in combination with other treatments, has been generally safe for patients with meningioma, with most side effects being mild, such as minor bleeding, nausea, and diarrhea. Serious side effects were rare, but included intestinal perforation and central nervous system bleeding in isolated cases.23678
How is the treatment with Electric Field Therapy and Bevacizumab unique for meningioma?
What is the purpose of this trial?
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.
Research Team
Priya U. Kumthekar
Principal Investigator
Northwestern University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bevacizumab intravenously and undergo electric field therapy using Optune daily over 18 hours. Courses repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 2 years.
Treatment Details
Interventions
- Bevacizumab
- NovoTTF-200A Device
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution
National Cancer Institute (NCI)
Collaborator