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

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT02847559
Trial Phases:	Phase II	Protocol IDs:	NU 16C02 (primary) NCI-2016-01026 STU00203030
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Northwestern University
NCI Full Details:	http://clinicaltrials.gov/show/NCT02847559

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. To determine the efficacy of Optune (tumor treating fields [TTF]) therapy with bevacizumab as assessed by progression free survival (PFS) for 6 months (PFS-6) in patients with recurrent or progressive meningioma.

SECONDARY OBJECTIVES:
I. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab.
II. To determine overall survival (OS).
III. To determine tumor response rate (TRR).
IV. To determine objective response rate (ORR).
V. To assess quality of life with treatment (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire.

OUTLINE:
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 of cycles 1-4. Beginning on day 1 of cycle 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-100A System) daily over 18 hours. Treatment repeat every 28 days for up to 6 months the absence of disease progression or unacceptable toxicity. Patients who achieve response after 6 months may continue on OPTUNE and bevacizumab at the discretion of their treating physician. At any point, if patients discontinue bevacizumab secondary to side effects, then they may continue Optune alone per treating physician’s discretion.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Treatment Sites in Georgia

Piedmont Healthcare
2001 Peachtree Road
Suite 645
Atlanta, GA 30309
www.piedmont.org/

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