27 Participants Needed

Electric Field Therapy + Bevacizumab for Meningioma

Recruiting at 6 trial locations
SC
Overseen ByStudy Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

This treatment combines Bevacizumab, which targets blood vessel growth in tumors, with Electric Field Therapy, which disrupts cancer cell division. This dual approach is novel for meningioma, especially for cases that do not respond to surgery or radiation.134910

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, MD | Northwestern ...

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

You are expected to live for at least 12 more weeks.
If you are capable of becoming pregnant, you need to have a recent negative pregnancy test before joining the study.
Patients must be able to comply with all protocol requirements
See 9 more

Exclusion Criteria

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.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bevacizumab intravenously and undergo electric field therapy using Optune daily over 18 hours. Courses repeat every 28 days.

6 months
Visits every 2 weeks for IV treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 2 years.

24 months
Follow-up visits every 3 months

Treatment Details

Interventions

  • Bevacizumab
  • NovoTTF-200A Device
Trial Overview 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.
Participant Groups
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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Avastin for:
  • Colorectal cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇺🇸
Approved in United States as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Glioblastoma
  • Renal cell carcinoma
  • Cervical cancer
  • Ovarian cancer
🇯🇵
Approved in Japan as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇨🇦
Approved in Canada as Avastin for:
  • 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

Trials
1,674
Recruited
989,000+

NovoCure Ltd.

Industry Sponsor

Trials
64
Recruited
6,100+

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

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 7 NF2 patients receiving bevacizumab, 36% of meningiomas showed a decrease in size, indicating that this treatment may help slow or reverse the growth of NF-related meningiomas.
Despite some positive effects, there is a significant risk of side effects, including a previously reported fatal case of intracerebral hemorrhage, highlighting the need for careful monitoring during treatment.
Effect of bevacizumab on intracranial meningiomas in patients with neurofibromatosis type 2 - a retrospective case series.Alanin, MC., Klausen, C., Caye-Thomasen, P., et al.[2019]
Bevacizumab showed some potential as a palliative treatment for aggressive pituitary adenomas in three patients who had exhausted standard therapies, with one patient experiencing disease stabilization for 18 months.
Despite some initial positive responses, the overall effectiveness of bevacizumab remains uncertain due to the advanced disease stage of the patients and the limited duration of treatment, highlighting the need for further research in this area.
Bevacizumab in Aggressive Pituitary Adenomas - Experience with 3 Patients.Osterhage, K., Rotermund, R., Droste, M., et al.[2021]
Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, shows promise in treating refractory meningioma, leading to both reduction in brain edema and actual tumor shrinkage, particularly in patients with higher-grade tumors (WHO grades II-III).
The review highlights the importance of the VEGF pathway in meningioma angiogenesis and suggests that further research into anti-VEGF therapies could provide effective treatment options for patients with relapsed or metastatic meningioma who have not responded to surgery or radiation.
Systemic therapy for relapsed/refractory meningioma: Is there potential for antiangiogenic agents?Dasanu, CA., Samara, Y., Codreanu, I., et al.[2019]

References

Effect of bevacizumab on intracranial meningiomas in patients with neurofibromatosis type 2 - a retrospective case series. [2019]
Bevacizumab in Aggressive Pituitary Adenomas - Experience with 3 Patients. [2021]
Systemic therapy for relapsed/refractory meningioma: Is there potential for antiangiogenic agents? [2019]
Antiangiogenic Molecules Suppressed Meningioma-Induced Neovascularization: A Corneal Angiogenesis Study. [2022]
Role of bevacizumab for treatment-refractory meningiomas: A systematic analysis and literature review. [2023]
A phase II trial of bevacizumab and everolimus as treatment for patients with refractory, progressive intracranial meningioma. [2022]
Antiangiogenic agents for nonmalignant brain tumors. [2022]
Bevacizumab therapy for adults with recurrent/progressive meningioma: a retrospective series. [2022]
Improvement in Visual Fields After Treatment of Intracranial Meningioma With Bevacizumab. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Multimodality Therapy of Patients with Refractory Meningiomas. [2020]
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