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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Electric Field Therapy — PROCEDURE
  Undergo electric field therapy using Optune device
• NovoTTF-200A Device — DEVICE
  Undergo electric field therapy using Optune device
• Quality-of-Life Assessment — PROCEDURE
  Ancillary studies

Study Details

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.

Key Dates

Start date

Aug 1, 2016

Status verified

Jun 2025

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (bevacizumab, electric field therapy)
  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.

Primary Outcome Measure

Progression Free Survival for 6 months (PFS-6) [ Time Frame: At 6 months ]

Central Contacts

• Study Coordinator
  (312)695-1301
  [email protected]

Locations (8)

Find similar trials in Santa Monica, CA

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