NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

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 by a 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