Combining electric field therapy and bevacizumab for treating recurrent meningioma

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

This study is testing if combining a new drug with a device that uses electric fields can help people with recurring meningiomas live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwestern University (other)
• Drugs / interventions: bevacizumab, radiation
• Locations: 8 sites (Santa Monica, California and 7 other locations)
• Trial ID: NCT02847559 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of combining bevacizumab, an investigational drug that inhibits blood vessel growth, with Optune, a device that delivers electric fields to disrupt tumor cell division, in patients with recurrent or progressive meningiomas. Participants will receive bevacizumab intravenously and use the Optune device for at least 18 hours daily. The primary goal is to assess progression-free survival over six months, while secondary objectives include overall survival, tumor response rates, and quality of life evaluations. Patients will be monitored for two years after treatment completion to evaluate long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients with a histologically confirmed diagnosis of grade 2 or 3 meningioma who have experienced disease recurrence after standard treatments.

Not a fit: Patients with meningiomas that are not recurrent or progressive, or those who have not undergone standard treatment protocols, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with recurrent meningiomas, potentially improving survival and quality of life.

How similar studies have performed: While the combination of electric field therapy and bevacizumab is novel for meningiomas, similar approaches have shown promise in other tumor types, indicating potential for success.

Eligibility criteria

Inclusion 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

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

Exclusion Criteria:

* 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

Where this trial is running

Santa Monica, California and 7 other locations

• John Wayne Cancer Center at Providence St. John's Health Center — Santa Monica, California, United States (COMPLETED)
• Miami Cancer Institute — Miami, Florida, United States (COMPLETED)
• Piedmont Healthcare — Atlanta, Georgia, United States (COMPLETED)
• Northwestern University — Chicago, Illinois, United States (RECRUITING)
• Northwestern University- Lake Forest Hospital — Lake Forest, Illinois, United States (ACTIVE_NOT_RECRUITING)
• Northwestern Medicine/ Cadence Health - CDH — Winfield, Illinois, United States (RECRUITING)
• Vidant Medical Center, East Caroling University — Greenville, North Carolina, United States (ACTIVE_NOT_RECRUITING)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Priya Kumthekar, MD — Northwestern University
• Study coordinator: Study Coordinator

Conditions: Anaplastic Meningioma, Atypical Meningioma, Grade II Meningioma, Grade III Meningioma, Recurrent Meningioma, Supratentorial Meningioma