RecruitingNot ApplicableNCT07404605

Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

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


Sponsor

Institute of Oncology Ljubljana

Enrollment

150 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Cutaneous melanoma frequently develops cutaneous and subcutaneous metastases, which may cause significant morbidity and negatively affect quality of life. Electrochemotherapy (ECT) is an established local treatment modality for cutaneous and subcutaneous tumor lesions that combines the administration of cytotoxic drugs with the application of electric pulses to increase drug uptake into tumor cells. In addition to its direct cytotoxic effects, electrochemotherapy may induce changes in the tumor microenvironment, including immune cell infiltration, vascular alterations, and other biological responses that could influence tumor control. The aim of this study is to evaluate changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases following electrochemotherapy with either intravenous bleomycin or intratumoral cisplatin. Tumor tissue samples collected before and after treatment will be analyzed to characterize microenvironmental changes and to compare treated and untreated lesions. The results of this study may improve understanding of biological effects of electrochemotherapy in melanoma metastases and support further development of treatment strategies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how electrochemotherapy — a treatment that uses brief electric pulses to drive chemotherapy drugs directly into skin cancer cells — changes the tumor environment in people with melanoma (skin cancer) that has spread to the skin or just under the skin. This may help researchers understand how to combine it with immunotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with melanoma (confirmed by biopsy) - You have skin or subcutaneous (under-the-skin) metastases that can be treated with electrochemotherapy - Electrochemotherapy with bleomycin or cisplatin has been recommended as part of your standard care **You may NOT be eligible if...** - You have a contraindication to electrochemotherapy or the study drugs (bleomycin or cisplatin) - You are pregnant or breastfeeding - You have severe health conditions that prevent the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREElectrochemotherapy

Electrochemotherapy is performed according to standard clinical procedures with application of electric pulses combined with administration of cytotoxic agents (intravenous bleomycin or intratumoral cisplatin) for treatment of cutaneous and subcutaneous melanoma metastases.


Locations(1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

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NCT07404605


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