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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older

• Histologically confirmed cutaneous melanoma

• Presence of cutaneous and/or subcutaneous metastases eligible for electrochemotherapy

• Candidate for electrochemotherapy with intravenous bleomycin or intratumoral cisplatin according to standard clinical practice

• Ability to provide written informed consent

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Klavdija Korošec
kkorosec@onko-i.si
+386 31630065
Backup
Neža Gros
ngros@onko-i.si
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 150
Treatments
Experimental: Electrochemotherapy (ECT)
Patients with cutaneous melanoma with cutaneous and/or subcutaneous metastases undergoing electrochemotherapy as part of clinical management. Electrochemotherapy is performed using intravenous bleomycin or intratumoral cisplatin. Tumor samples are collected before and after treatment for analysis of tumor microenvironment changes.
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana

This content was sourced from clinicaltrials.gov