Optune and Bevacizumab for Recurrent Meningioma
This study is testing if combining Bevacizumab (a medication that blocks blood vessel growth) with Optune (a device that uses electric fields) can help treat recurrent or progressive meningioma (a type of brain tumor). Bevacizumab and Optune are considered investigational for meningioma because the FDA has not yet approved them for this specific use. Researchers hope Bevacizumab will starve the tumor of nutrients, while Optune uses electric fields to disrupt tumor cell growth. You may be eligible if you have a Grade 2 or 3 meningioma that has come back or is getting worse. The main goal is to see how many patients are free from tumor progression for at least 6 months. The current status of this study is unclear, and it plans to enroll 27 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 27 participants.
- What's involved
- You would receive Bevacizumab intravenously every 2 or 3 weeks and use the Optune device daily for over 18 hours. These treatments continue in 28-day cycles as long as your disease doesn't worsen or side effects are manageable.
- Compensation
- Not stated in the trial record.
- Follow-up
- After completing study treatment, you will be followed up every 3 months for 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02847559
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
Recruiting
PHASE2Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~27 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:BevacizumabElectric Field TherapyNovoTTF-200A DeviceQuality-of-Life Assessment
At a glance
Recruiting sites
2 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival for 6 months (PFS-6)
Measured over At 6 months
Conditions
Where it's being run
8 sites across 6 statesIllinois3
California1
Florida1
Georgia1
North Carolina1
Pennsylvania1
Study leadership
- Priya Kumthekar, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have a histologic diagnosis of meningioma, World Health Organization (WHO) grade 2 or 3 (atypical or anaplastic)
Patient's tumor must have a supratentorial component
Patients must have measurable or non-measurable (evaluable) disease recurrence; recurrence must be documented by magnetic resonance imaging (MRI) or computed tomography (CT) scan
All patients must have developed recurrent disease/progression (evidence of recurrence to be established by MRI or CT 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 previous systemic treatment regimens with the exception of bevacizumab (no limit to number of prior therapies); a 4 week wash-out period prior to registration is mandatory for all systemic treatments
Life expectancy of at least 12 weeks
Karnofsky performance status \>= 60%
Patients must have adequate bone marrow, kidney, and liver function, (within 14 days prior to registration), defined as:
Absolute neutrophil count (ANC) \>= 1500/uL (with/without growth factor)
Hemoglobin (Hgb) \>= 9 g/dL (with/without transfusion)
Platelets \>= 100,000/L
Aspartate aminotransferase (AST) and alanine aminotransferase (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
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
Exclusion
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 infratentorial disease and spinal 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
Previous treatment with bevacizumab
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab are not eligible
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
Chronic, systemic treatment with immunosuppressive agents; patients who require a stable dose of corticosteroids for control of cerebral edema are eligible; topical or inhaled steroids are also allowed
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
What this trial measures
- Progression Free Survival for 6 months (PFS-6)At 6 months
Determine the efficacy of combination therapy of bevacizumab and Optune (TTF) as assessed by Progression Free Survival at 6 months