Electric Field Therapy and Bevacizumab in Treating Patients with Recurrent Glioblastoma

Inclusion Criteria

• Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy
• Patients with up to two prior recurrences are allowed
• Karnofsky performance status >= 70%
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Platelets >= 100 X 10^9/L
• Hemoglobin (Hgb) > 9 g/dL
• Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN
• Serum creatinine =< 1.5 x ULN
• International normalized ratio (INR) =< 1.5
• Minimum interval since completion of radiation treatment is 12 weeks
• Minimum interval since last drug therapy: * 3 weeks since last non-cytotoxic therapy * 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; female patients of child-bearing potential must have negative pregnancy test
• Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for >= three years
• Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment

Exclusion Criteria

• Patients who have had previous treatment with bevacizumab and/ or NovoTTF 100A system
• Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury =< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device =< 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
• Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following: * History or presence of serious uncontrolled ventricular arrhythmias * Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE) * Uncontrolled hypertension (defined as systolic blood pressure [SBP] >= 160 mm Hg or diastolic blood pressure [DBP] >= 100 mm Hg while on anti-hypertensive medications)
• Patients with cirrhosis, or active viral or nonviral hepatitis
• Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
• Infra-tentorial tumor
• Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• Known sensitivity to conductive hydrogels
• Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
• Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
• Pregnant or breast-feeding women
• Patients unwilling or unable to comply with the protocol
• Patients with leptomeningeal disease