Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma

NAEnrolling by invitationINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

November 30, 2025

Conditions
Cutaneous Malignant Melanoma
Interventions
PROCEDURE

Electrochemotherapy with Intratumoral Cysplatin

ECT will be performed directly after the intratumorally administration of cysplatin (0,5-2 mg/cm3 tumor). CliniporatorTM (IGEA S.P.A., Carpi, Italy) will be used to apply the pulses (8 pulses, 1300 V/cm, 100 μs, 5 kHz). Triggering of the electrical pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart. The type of electrode used will be selected according to the size and location of the tumors.

PROCEDURE

Electrochemotherapy with Intravenous Bleomycin

ECT will be performed within 8 - 28 minutes after intravenous bolus administration of bleomycin (15.000 IU/m2 BSA). CliniporatorTM (IGEA S.P.A., Carpi, Italy) will be used to apply the pulses (8 pulses, 1300 V/cm, 100 μs, 5 kHz). Triggering of the electrical pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart. The type of electrode used will be selected according to the size and location of the tumors.

Trial Locations (1)

1000

Institute of Oncology Ljubljana, Ljubljana

All Listed Sponsors
collaborator

Slovenian Research and Innovation Agency

UNKNOWN

lead

Institute of Oncology Ljubljana

OTHER