RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2016-08-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02847559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

(312)695-1301

cancertrials@northwestern.edu

Principal Investigator

Priya Kumthekar, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

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

Santa Monica, California, 90404

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

Piedmont Healthcare

Atlanta, Georgia, 30309

United States

Northwestern University

Chicago, Illinois, 60611

United States

Northwestern University- Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Northwestern Medicine/ Cadence Health - CDH

Winfield, Illinois, 60190

United States

Vidant Medical Center, East Caroling University

Greenville, North Carolina, 27834

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Northwestern University

Priya Kumthekar, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2016-08-01

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

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