NanoKnife Irreversible Electroporation System in Treating Patients with Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

Inclusion Criteria

• Must be found to have locally advanced unresectable disease following standard chemotherapy and/or (+/-) radiotherapy as demonstrated with computed tomography (CT)/magnetic resonance imaging (MRI) and surgical evaluation
• Must have an international normalized ratio (INR) < 1.5
• Are willing and able to comply with the protocol requirements
• Are able to comprehend and willing to sign an informed consent form
• Tumor size is measurable - measurable tumor criteria will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Exclusion Criteria

• A baseline creatinine reported as > 2.0 mg/dL
• Have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
• Inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife system
• Tumor size not measurable
• Known history of contrast allergy that cannot be medically managed
• Known hypersensitivity to the metal in the electrodes (stainless steel 304 L) that cannot be medically managed
• Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atricurium, cisatricurium, etc.)
• Women who are pregnant or currently breast feeding
• Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, intrauterine device [IUD], ring, condom, sponge, foam)
• Have taken an investigational agent within 30 days of visit 1
• Have implanted cardiac pacemakers or defibrillators
• Have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
• Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
• Have a recent history of myocardial infarction (within the past 2 months)
• Have Q-T intervals greater than 550 ms unless treated with an Accysync model 72 synchronization system controlling the NanoKnife system’s output pulses
• Evidence of distant metastases of stage IV
• Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife irreversible electroporation (IRE) system
• Receive non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 gray (Gy) delivered conventionally