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

NCT02847559 | Recruiting Phase 2 DMC

• 4 other identifiers: NU 16C02STU00203030P30CA060553NCI-2016-01026
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Anaplastic (Malignant) Meningioma; Atypical Meningioma; Grade II Meningioma; Grade III Meningioma; Recurrent Meningioma; Supratentorial Meningioma

Outcome Measures

Primary Outcomes (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

  At 6 months

Secondary Outcomes (3)

• Overall Survival (OS)

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

• Tumor Response Rate (TRR)

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

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

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

Study Arms (1)

Treatment (bevacizumab, electric field therapy)

EXPERIMENTAL

Patients 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 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.

Biological: Bevacizumab; Procedure: Electric Field Therapy; Device: NovoTTF-200A Device; Procedure: Quality-of-Life Assessment

Interventions

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF

Treatment (bevacizumab, electric field therapy)

Electric Field Therapy PROCEDURE

Undergo electric field therapy using Optune device

Treatment (bevacizumab, electric field therapy)

NovoTTF-200A Device DEVICE

Undergo electric field therapy using Optune device

Also known as: NovoTTF-200A, NovoTTF-200A System, NovoTTFields, NovoTumor Treatment Fields, Optune, Optune Device

Treatment (bevacizumab, electric field therapy)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (bevacizumab, electric field therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• NovoCure Ltd.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (8)

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

Santa Monica, California, 90404, United States

COMPLETED

Miami Cancer Institute

Miami, Florida, 33176, United States

COMPLETED

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

COMPLETED

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern University- Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

ACTIVE NOT RECRUITING

Northwestern Medicine/ Cadence Health - CDH

Winfield, Illinois, 60190, United States

RECRUITING

Vidant Medical Center, East Caroling University

Greenville, North Carolina, 27834, United States

ACTIVE NOT RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

Bevacizumab; Immunoglobulin G; Disulfides

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Priya Kumthekar, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

(312)695-1301; cancertrials@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)