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Anaplastic (Malignant) MeningiomaPhase 2NCT02847559

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

A Phase 2 study testing Bevacizumab, Electric Field Therapy and NovoTTF-200A Device in people with Anaplastic (Malignant) Meningioma and Atypical Meningioma, run by Northwestern University at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Electric Field Therapy and NovoTTF-200A Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesUnited States
Study dates
1 Aug 2016to 1 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a histologic diagnosis of meningioma, World Health Organization (WHO) grade 2 or 3 (atypical or anaplastic)
  • Patients must have measurable disease recurrence. Recurrence must be documented by MRI scan.
  • 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).
  • Patients may have had any 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
  • Patients must be age ≥ 18 years. Both males and females and patients from all ethnic backgrounds are eligible.
  • Life expectancy of at least 12 weeks.
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  • Karnofsky performance status ≥ 60 % (see appendix 1).
  • Patients must have adequate bone marrow, kidney, and liver function, (within 14 days prior to registration), defined as: Platelets ≥ 100,000/L, PT/INR/PTT ≤ 1.5x ULN (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients), AST and ALT ≤ 2.5 x institutional upper limit of normal (ULN), Total bilirubin ≤ 1.5 x institutional ULN, Serum creatinine ≤ 1.5 x institutional ULN
  • 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)
  • FOCBP must have a negative serum or urine pregnancy test within 14 days prior to registration on study
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Patients must be able to comply with all protocol requirements

Who cannot join

  • Patients who have had major surgery or significant traumatic injury within 4 weeks prior to registration, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study
  • Patients who have had minor surgical procedures (with the exception of the placement of porta cath or other central venous access) within 7 days prior to registration
  • Patients with spine only disease
  • Patients may not be receiving any other investigational agents; (i.e. 28-day washout period from prior investigational drug is required)
  • Patients may not receive any other anti-cancer therapies, within 28 days prior to registration and throughout the duration of this trial
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab are not eligible
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  • Patients with active implanted medical device, a skull defect (such as, missing bone with no replacement), a shunt or bullet fragments; examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts
  • Patients with known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
  • Patients with proteinuria within 14 days of registration as demonstrated by either: urine protein creatinine (UPC) ratio >= 1.0 at screening OR urine dipstick for proteinuria 2+ (patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate =< 1 g of protein/24 hours to be eligible)
  • Patients with a serious non-healing wound, active ulcer, or untreated bone fracture
  • Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Patients with history of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) within 28 days prior to registration
  • History of myocardial infarction or unstable angina within 6 months of registration
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and /or diastolic blood pressure > 100 mmHg)
  • History of stroke or transient ischemic attack within 6 months prior to registration
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to registration
  • Patients who have any severe and/or uncontrolled intercurrent medical conditions including, but not limited to any of the following, are not eligible:
  • Ongoing or active wound infection requiring concurrent systemic antibiotic treatment; there is no mandatory duration of time that a patient has to be off antibiotics, but the treating physician has to deem the infection as effectively treated prior to enrollment
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia (New York Heart Association [NYHA] criteria)
  • Psychiatric illness/social situations that would limit compliance with study requirements, prevent patient comprehension of the nature of, and risk associated with, the study
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
  • Female patients who are pregnant or nursing are not eligible
  • Patients with evidence of increased intracranial pressure (midline shift >5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Northwestern University

    Chicago, Illinois, 60611

  • Vidant Medical Center, East Caroling University

    Greenville, North Carolina, 27834

  • Northwestern University- Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Miami Cancer Institute

    Miami, Florida, 33176

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • John Wayne Cancer Center at Providence St. John's Health Center

    Santa Monica, California, 90404

  • Northwestern Medicine/ Cadence Health - CDH

    Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in the Setting of Recurrent or Progressive Meningioma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. TTo determine the efficacy of Optune (TTF) therapy with Bevacizumab as assessed by Progression Free Survival (PFS) at 6 months (PFS-6) in patients with recurrent or progressive meningioma. PFS-6 will be defined from the time of registration to the time of confirmed progression. In cases where this might be unclear, patients may continue on trial and if progression is confirmed later, then the original date where first changes occurred will be used.

SECONDARY OBJECTIVES:

  1. 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 FACT-Br questionnaire.

OUTLINE:

This is a trial of Optune with concurrent standard of care treatment bevacizumab. Both treatments can start simultaneously with either starting first, but both must start within a window of 1 week. Patients receive bevacizumab intravenously (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 for at least18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are responding will remain on study treatment for 6 months.After 6 months, patients may still continue on OPTUNE and Bevacizumab at the discretion of their treating physician. NOTE: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.

Being tested
Bevacizumab, Electric Field Therapy, NovoTTF-200A Device, Quality-of-Life Assessment
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • Electric Field TherapyProcedure or surgery

    Undergo electric field therapy using Optune device

  • NovoTTF-200A DeviceDevice

    Also called NovoTTF-200A, NovoTTF-200A System, NovoTTFields, NovoTumor Treatment Fields

    Undergo electric field therapy using Optune device

  • Quality-of-Life AssessmentProcedure or surgery

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02847559
Study groupRoleWhat they receive
Treatment (bevacizumab, electric field therapy)ExperimentalPatients 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 15 mg/kg 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.
Receives: Biological: Bevacizumab; Procedure: Electric Field Therapy; Device: NovoTTF-200A Device; Procedure: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival for 6 months (PFS-6)

    Determine the efficacy of combination therapy of bevacizumab and Optune (TTF) as assessed by Progression Free Survival at 6 months. PFS-6 will be defined from the time of registration to the time of confirmed progression. In cases where this might be unclear, patients may continue on trial and if progression is confirmed later, then the original date where first changes occurred will be used.

    Measured: At 6 months

Secondary outcomes (5)

  1. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab.

    To collect the safety and tolerability data for Optune (TTF) in combination with bevacizumab, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to Optune and bevacizumab, according the NCI-CTCAE version 4.03.

    Measured: All subjects who receive at least 1 dose of bevacizumab and use the Optune device for at least 1 day will be evaluable for this endpoint. AEs are followed from treatment initiation through 30 days after the last dose.

  2. Overall Survival (OS)

    OS will be defined from the time of registration to death and will be assessed for up to 2 years.

    Measured: From time of registration to death, assessed up to 2 years

  3. Tumor Response Rate (TRR)

    Imaging (MRI or CT scan) will assess radiographic response in terms of complete response, partial response, stable disease, and progressive disease. The iRANO criteria will be used for response assessment. TRR will be assessed in terms of: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).

    Measured: At baseline and every eight weeks, assessed up to 12 months

  4. To determine Objective Response Rate (ORR)

    ORR will be measured via Brain MRI (or CT with contrast if contraindicated). ORR will beassessed in terms of: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).

    Measured: Imaging studies will be performed at baseline, during week eight (prior to cycle 3), and every eight weeks thereafter (prior to odd number cycles).

  5. Quality of Life (QOL) with treatment using FACT-Br questionnaire

    To assess QOL with treatment the Functional Assessment of Cancer Therapy-Brain version 4.0 (FACT-Br) questionnaire will be administered.

    Measured: At baseline, on Day 1 of every cycle, and 1 month after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study start1 Aug 2016
  3. Primary completion11 Aug 2025
  4. Study completion1 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847559
Sponsor's protocol ID
NU 16C02
Other IDs
STU00203030, NU 16C02, P30CA060553, NCI-2016-01026
Status last verified
Sep 2026
First submitted
25 Jul 2016
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Electric Field Therapy and NovoTTF-200A Device in people with Anaplastic (Malignant) Meningioma and Atypical Meningioma, run by Northwestern University at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival for 6 months (PFS-6) (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02847559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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