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New treatment option for Anaplastic (Malignant) Meningioma
Official title Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
ClinicalTrials.gov ID: NCT02847559
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anaplastic (malignant) meningioma.
Also referred to as Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- All patients must have developed recurrent disease/progression (evidence of recurrence to be established by MRI or CT scan with contrast; there is no...
- Surgical resection, if possible;
You likely can't join if
- Patients who have had major surgery or significant traumatic injury within 4 weeks prior to registration, patients who have not recovered from the...
- Patients who have had minor surgical procedures (with the exception of the placement of porta cath or other central venous access) within 7 days...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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+...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lake Forest, Illinois, United States
- Winfield, Illinois, United States
- Greenville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lake Forest, Illinois, United States; Winfield, Illinois, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.