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
Maryland
Baltimore
Glen Burnie
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.
Trial Phase Phase NA
Trial Type Treatment
Lead Organization
University of Maryland / Greenebaum Cancer Center
Principal Investigator
Cherif N. Boutros
- Primary ID 1227GCC
- Secondary IDs NCI-2016-00337
- Clinicaltrials.gov ID NCT02041936