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

Launched by INSTITUTE OF ONCOLOGY LJUBLJANA · Apr 24, 2024

Keywords

ClinConnect Summary

The study is prospective. The primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy (ECT), based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.

In the study 10-15 patients will be enrolled and devided in two arms, ECT with bleomycin and ECT with cysplatin.

ECT will be offered to patients with cuteaneous melanom...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • more than 4 cytologically and/or histologically confirmed intransit or distant cutaneous/subcutaneous cutaneous melanoma metastases
• • ECT should be proposed as a treatment in the multidisciplinary tumor board
• • cutaneous/subcutaneous melanoma metastases, that can be excised under local anesthesia with primary wound closure, minimal morbidity of the procedure (risk of complications \< 5%) and nocosmetic or functional consequences of the procedure
• • stage IIIB, IIIC or IV of the disease
• • age over 18 years
• • performance status World Health Organization more than 2
• • patients must give informed consent
• Exclusion Criteria:
• • age less than 18 years
• • polimorbidity
• • performance status World Health Organization more than 2
• • high risk for intervention under general anesthesia;
• • wound closure would require coverage with a skin graft or local flap;
• • undesirable cosmetic or functional consequences would be expected (face, extensor side of joints)
• • patients incapable of understanding the aim of the study or disagree with the entering into the clinical study