Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer

Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator").

In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: Electrochemotherapy with Bleomycin

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • University of Verona Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced CT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure
• Cytohistological diagnosis of pancreatic cancer
• Age > 18 and < 80
• Stable disease after chemotherapy (no tumor progression, no oncomarkers (Carbohydrate Antigen 19-9 [CA 19-9] or Carcinoembryonic antigen [CEA]) increase
• Performance Status 0 sec. ECOG (Eastern Cooperative Oncology Group)
• Written informed consent

Exclusion Criteria:

• Resectable pancreatic cancer as assessed by multidisciplinary meeting
• Stage IV disease
• Patients receiving fenitoin, phosphofenitoin or living vaccines
• Pregnancy
• Progressive disease (either dimensional and not only by stage)
• < 18 years old and > 80

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of adverse events related with electrochemotherapy (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications are distinct in early (during hospitalization) and late (bile duct stenosis) that may appear during follow-up	through study completion, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Number of procedures planned actually performed	through study completion, 1 year
Tumour response	Analysis of effects of electrochemotherapy on tumor using RECIST criteria	12 months
Quality of life	Analysis of quality of life using the Karnovsky performance index	12 months
Quality of life	Analysis of quality of life using the pain numeric scale	12 months
Survival	Survival analysis through the calculation of overall survival	12 months
Survival	Survival analysis through the calculation of progression free survival survival	12 months
Immunomonitoring	Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure	From baseline to the first month

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: IGEA

Publications and helpful links

General Publications

• Granata V, Fusco R, Piccirillo M, Palaia R, Petrillo A, Lastoria S, Izzo F. Electrochemotherapy in locally advanced pancreatic cancer: Preliminary results. Int J Surg. 2015 Jun;18:230-6. doi: 10.1016/j.ijsu.2015.04.055. Epub 2015 Apr 24.
• Bimonte S, Leongito M, Granata V, Barbieri A, Del Vecchio V, Falco M, Nasto A, Albino V, Piccirillo M, Palaia R, Amore A, Giacomo Rd, Lastoria S, Setola SV, Fusco R, Petrillo A, Izzo F. Electrochemotherapy in pancreatic adenocarcinoma treatment: pre-clinical and clinical studies. Radiol Oncol. 2016 Feb 16;50(1):14-20. doi: 10.1515/raon-2016-0003. eCollection 2016 Mar 1.
• Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6.
• Girelli R, Prejano S, Cataldo I, Corbo V, Martini L, Scarpa A, Claudio B. Feasibility and safety of electrochemotherapy (ECT) in the pancreas: a pre-clinical investigation. Radiol Oncol. 2015 Mar 25;49(2):147-54. doi: 10.1515/raon-2015-0013. eCollection 2015 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents; Antibiotics, Antineoplastic; Bleomycin
• Other Study ID Numbers: SP-ECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No