NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

NCT01369420 | Completed Phase 2

• 1 other identifier: ONC-208
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.

Conditions

Pancreatic Adenocarcinoma

Keywords

locoregional cancer therapy; pancreatic cancer; unresectable pancreatic cancer; pancreatic adenocarcinoma; locally advanced, unresectable pancreatic cancer; pancreatic cancer tumor ablation; NanoKnife tumor ablation for pancreatic cancer; NanoKnife LEDC system tumor ablation; Non thermal ablation; Irreversible electroporation for pancreatic cancer treatment; IRE for unresectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  * reported adverse events and adverse effects/events (serious and non serious), * unanticipated adverse events and device complaints, * safety laboratory tests (hematology, chemistry, amylase, lipase), * vital signs, * physical findings (including symptoms, vital signs and weight changes)

  90 days

Secondary Outcomes (1)

• Efficacy

  90 days

Interventions

NanoKnife Low Energy Direct Current (LEDC) System Ablation DEVICE

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Also known as: ◦ Low Energy Direct Current (LEDC) System, ◦ HVP01 Electroporation System, ◦ NanoKnife LEDC System, ◦ NanoKnife IRE System, ◦ Non-Thermal Irreversible Eletroporation (NTIRE) System, ◦ Angiodynamics IRE System, ◦ Non-Thermal Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female
• \>/= 18 years of age
• meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
• tumor size must be \< 4 cm and must be measurable
• must have an INR \<1.5
• must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
• are willing and able to comply with the protocol requirements
• are able to comprehend and willing to sign an Informed Consent Form (ICF)

You may not qualify if:

• 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 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
• known history of contrast allergy that cannot be medically managed
• known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
• unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)
• women who are pregnant or currently breast feeding
• women of childbearing potential who are not utilizing an acceptable method of contraception
• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (1)

Policlinico "G.B. Rossi", University of Verona, Department of Surgery

Verona, Verona, 37134, Italy

Location

Related Publications (10)

• Varshney S, Sewkani A, Sharma S, Kapoor S, Naik S, Sharma A, Patel K. Radiofrequency ablation of unresectable pancreatic carcinoma: feasibility, efficacy and safety. JOP. 2006 Jan 11;7(1):74-8.

  PMID: 16407624 BACKGROUND

• Spiliotis JD, Datsis AC, Michalopoulos NV, Kekelos SP, Vaxevanidou A, Rogdakis AG, Christopoulou AN. Radiofrequency ablation combined with palliative surgery may prolong survival of patients with advanced cancer of the pancreas. Langenbecks Arch Surg. 2007 Jan;392(1):55-60. doi: 10.1007/s00423-006-0098-5. Epub 2006 Nov 7.

  PMID: 17089173 BACKGROUND

• Hadjicostas P, Malakounides N, Varianos C, Kitiris E, Lerni F, Symeonides P. Radiofrequency ablation in pancreatic cancer. HPB (Oxford). 2006;8(1):61-4. doi: 10.1080/13651820500466673.

  PMID: 18333241 BACKGROUND

• Wu Y, Tang Z, Fang H, Gao S, Chen J, Wang Y, Yan H. High operative risk of cool-tip radiofrequency ablation for unresectable pancreatic head cancer. J Surg Oncol. 2006 Oct 1;94(5):392-5. doi: 10.1002/jso.20580.

  PMID: 16967436 BACKGROUND

• Matsui Y, Nakagawa A, Kamiyama Y, Yamamoto K, Kubo N, Nakase Y. Selective thermocoagulation of unresectable pancreatic cancers by using radiofrequency capacitive heating. Pancreas. 2000 Jan;20(1):14-20. doi: 10.1097/00006676-200001000-00002.

  PMID: 10630378 BACKGROUND

• Elias D, Baton O, Sideris L, Lasser P, Pocard M. Necrotizing pancreatitis after radiofrequency destruction of pancreatic tumours. Eur J Surg Oncol. 2004 Feb;30(1):85-7. doi: 10.1016/j.ejso.2003.10.013.

  PMID: 14736529 BACKGROUND

• Connor S, Raraty MG, Neoptolemos JP, Layer P, Runzi M, Steinberg WM, Barkin JS, Bradley EL 3rd, Dimagno E. Does infected pancreatic necrosis require immediate or emergency debridement? Pancreas. 2006 Aug;33(2):128-34. doi: 10.1097/01.mpa.0000234074.76501.a6. No abstract available.

  PMID: 16868477 BACKGROUND

• Raraty MG, Connor S, Criddle DN, Sutton R, Neoptolemos JP. Acute pancreatitis and organ failure: pathophysiology, natural history, and management strategies. Curr Gastroenterol Rep. 2004 Apr;6(2):99-103. doi: 10.1007/s11894-004-0035-0.

  PMID: 15191686 BACKGROUND

• Chan YC, Leung PS. Acute pancreatitis: animal models and recent advances in basic research. Pancreas. 2007 Jan;34(1):1-14. doi: 10.1097/01.mpa.0000246658.38375.04.

  PMID: 17198179 BACKGROUND

• Freitag M, Standl TG, Kleinhans H, Gottschalk A, Mann O, Rempf C, Bachmann K, Gocht A, Petri S, Izbicki JR, Strate T. Improvement of impaired microcirculation and tissue oxygenation by hemodilution with hydroxyethyl starch plus cell-free hemoglobin in acute porcine pancreatitis. Pancreatology. 2006;6(3):232-9. doi: 10.1159/000091962. Epub 2006 Mar 9.

  PMID: 16534248 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Claudio Bassi, M.D.

  Policlinico "G.B. Rossi", University of Verona, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

IT (1)