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

Cancer Type
Brain & Spinal Cord Tumor
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
NU 16C02 (primary)
Study Sponsor
Northwestern University


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.


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.

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.

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.


  1. Patients must have a histologic diagnosis of meningioma, World Health Organization (WHO) grade 2 or 3 (atypical or anaplastic)
  2. Patients must have measurable disease recurrence; recurrence must be documented by magnetic resonance imaging (MRI) scan
  3. All patients must have developed recurrent disease/progression (evidence of recurrence to be established by MRI scan with contrast; there is no limit to the number of relapses) after receiving all standard treatments, which must include the following: * Surgical resection, if possible; * Definitive radiation therapy for unresectable meningioma, or for recurrent meningioma after resection * (Note: At registration, patients must be at least 28 days post-surgery, and must be at least 28 days post-radiation therapy, with resolution of related cytotoxicities down to grade 2)
  4. Patients may have had previous systemic treatment regimens (no limit to number of prior therapies); patients with prior treatment with bevacizumab are eligible for enrollment into the study; NOTE: except for bevacizumab, a 28 day wash-out period prior to registration is mandatory for all systemic treatments
  5. Patients must be age >= 18 years. Both males and females and patients from all ethnic backgrounds are eligible
  6. Life expectancy of at least 12 weeks
  7. Karnofsky performance status >= 60%
  8. Platelets >= 100,000/L (within 14 days prior to registration)
  9. Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients) (within 14 days prior to registration)
  10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN) (within 14 days prior to registration)
  11. Total bilirubin =< 1.5 x institutional ULN (within 14 days prior to registration)
  12. Serum creatinine =< 1.5 x institutional ULN (within 14 days prior to registration)
  13. Females of child-bearing potential (FOCBP) and males with partners of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study treatment; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; likewise, if the female partner of a male patient becomes pregnant or suspect she is pregnant, he should inform his treating physician immediately NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  14. FOCBP must have a negative serum or urine pregnancy test within 14 days prior to registration on study
  15. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  16. Patients must be able to comply with all protocol requirements

Treatment Sites in Georgia

Piedmont Healthcare

2001 Peachtree Road
Suite 645
Atlanta, GA 30309

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.