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

This clinical trial studies how well NanoKnife irreversible electroporation system works in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery. NanoKnife irreversible electroporation system is a non-thermic (not produced by heat) ablative therapy (the removal or destruction of a tissue or its function) that has the potential to achieve pancreatic ablation without harming the surrounding vascular and ductal structures.

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

PRIMARY OBJECTIVES:

I. To evaluate the short and intermediate term outcomes of the NanoKnife Irreversible Electroporation (IRE) System when used to treat unresectable pancreatic cancer.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of this device in treating symptoms of unresectable pancreatic cancer.

OUTLINE:

Patients undergo NanoKnife IRE.

After completion of study treatment, patients are followed up on day 1, 2, 4, 7, 14, 21, and 30 and then every 3 months for up to 2 years.

Lead Organization
University of Maryland / Greenebaum Cancer Center

Principal Investigator
Cherif N. Boutros