Phase 2 Study Combining Bevacizumab and Optune Electric Field Therapy for Adults With Recurrent or Progressive Grade 2 or 3 Meningioma

What this Trial Is About

This research study evaluates the effects of combining bevacizumab, an investigational drug that blocks new blood vessel growth, with Optune, an investigational device delivering electric field therapy, on patients with recurrent or progressive grade 2 or 3 meningiomas. The study aims to determine progression-free survival at 6 months and assess overall survival, tumor response, and quality of life in these patients. The research addresses a need for new treatment options for meningiomas that have returned or worsened after standard therapies. Participants receive bevacizumab intravenously on days 1 and 15 of the first four 28-day treatment courses. From course 5 onward, patients may choose to continue bevacizumab every 2 or 3 weeks. They also use the Optune device daily for at least 18 hours, which delivers electrical currents to slow tumor growth by disrupting cell division. Treatment continues in repeated cycles until the disease progresses or unacceptable side effects occur. After treatment ends, patients are followed every 3 months for up to 2 years. During the study, participants undergo regular MRI or CT scans to document tumor recurrence, and their quality of life is assessed using a questionnaire. Safety is monitored through laboratory tests evaluating blood counts and organ function. The main measure is progression-free survival at 6 months, with secondary measures including overall survival, tumor response rate, and quality of life. The study involves ongoing monitoring to track treatment effects and patient well-being during and after the therapy period.

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