Treatment of Liver Metastases With Electrochemotherapy

NCT01264952 | Completed Phase 1 Results DMC

• 1 other identifier: 03-Z 16/KSOPKR-6
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and II. The study will include 10-15 patients with colorectal cancer with synchronous or metachronous liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm in the largest diameter. Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US) in a monthly interval. Two or three month after the first operation the treated and untreated metastases will be resected and through histological analyses performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

Conditions

Liver Metastases

Keywords

Liver metastases of colorectal cancer; Bleomycin; Electrochemotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)

  After operation on day 7

Secondary Outcomes (2)

• Number of Participants With Non-Serious Adverse Events

  After operation on tha days 2, 7, 30, monthly

• Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology

  After operation or 1st day after operation, 7th day, 30th day, monthly

Interventions

Electrochemotherapy PROCEDURE

Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin (15 mg/m2), within 5-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes. The maximum duration of procedure is 90 minutes.

Also known as: Device: Cliniporator Vitae®, Drug: Bleomicin PHC 15 e. (United States Pharmacopeia - USP)

Eligibility Criteria

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

You may qualify if:

• Patients with measurable liver metastases, presented simultaneously with primary tumor, aimed at primary tumor resection and in a 2-3 month interval resection of liver metastases. One metastasis will be treated by electrochemotherapy, not larger than 3 cm in diameter.
• Metastasis has to be accessible for application of electrochemotherapy during the operation, without major liver manipulation or mobilization in order not to create situation that would hamper feasibility of the second operation; resection of metastases.
• Patients with metachronous liver metastases, that are positioned in unresectable liver area, near blood vessels, but inoperable patients.
• Recurrent liver metastases, not more than 3, that are not larger than 3 cm in diameter.
• Histologically and cytologically confirmed cancer, any histological differentiation.
• Life expectancy more than 3 month.
• Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≥ 2.
• Age more than 18.
• The patient must be offered standard treatment.
• Electrochemotherapy is offered to the patients in the case of the disease progression during the standard treatment, in the case or metastases recurrence, or when they refuse standard treatment.
• Treatment free interval 2-5 weeks, depending on the drugs used.
• Patient must be mentally capable of understanding the information given.
• Patient must give informed consent.

You may not qualify if:

• Metastases more than 3 cm in diameter.
• Synchronous unresectable metastases.
• Metachronous unresectable metastases or bigger than 3 cm in diameter.
• Visceral, bone or diffuse metastases.
• Coagulation disturbances.
• Allergic reaction to bleomycin, or cumulative dose of 250 mg/m2 bleomycin received.
• Impaired kidney function (creatinin \> 150 µmol/l).
• Patients with hearth failure or pace maker.
• Patients with epilepsy.
• Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
• Pregnancy.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Edhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, Zupanic A, Mali B, Jarm T, Pavliha D, Marcan M, Gasljevic G, Gorjup V, Music M, Vavpotic TP, Cemazar M, Snoj M, Sersa G. Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85. doi: 10.7785/tcrt.2012.500224.

  PMID: 21895032 DERIVED

MeSH Terms

Interventions

Electrochemotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Results Point of Contact

• Title: Gregor Sersa, PhD
• Organization: Institute of Oncology Ljubljana

gsersa@onko-i.si

+386 1 5879 434

Study Officials

• Eldar Gadzijev, MD, PhD

  Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

• Gregor Sersa, PhD (Biol.)

  Institute of Oncology Ljubljana, Department of Experimental Oncology, Ljubljana, Slovenia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 22, 2010
• Study Start: November 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 24, 2020
• Results First Posted: January 1, 2015

Record last verified: 2020-11

Locations

SL (1)