MELANOMA, SKIN NEOPLASMS
Conditions
Keywords
MELANOMA
Brief 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.
Detailed description
This is a prospective interventional clinical study designed to investigate electrochemotherapy-induced changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases. Electrochemotherapy is a local treatment approach that combines electroporation with cytotoxic agents in order to increase intracellular drug delivery and enhance tumor cell death. The treatment is routinely used for superficial tumor lesions, including melanoma metastases, and can be performed using intravenous bleomycin or intratumoral cisplatin. The primary objective of this study is to characterize changes in the tumor microenvironment in melanoma metastases following electrochemotherapy. Tumor tissue samples will be collected from untreated lesions and from lesions treated with electrochemotherapy. Histopathological and immunohistochemical analyses will be performed to evaluate changes in the tumor microenvironment, including cellular and stromal components, immune-related features, and other relevant biological markers. The study will include patients with cutaneous melanoma presenting with cutaneous and/or subcutaneous metastases who are eligible for electrochemotherapy as part of their clinical management. Electrochemotherapy will be performed according to established clinical procedures using intravenous bleomycin or intratumoral cisplatin. Biopsy or surgical samples will be collected before and after treatment to enable comparative analyses of treated and untreated tumor tissue. Collected clinical and pathological data will be used to assess associations between treatment-related microenvironmental changes and patient and lesion characteristics. The study aims to provide additional insight into biological effects of electrochemotherapy beyond local tumor control and may contribute to improved understanding of mechanisms involved in treatment response.
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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm prospective interventional study evaluating tumor microenvironment changes in melanoma metastases before and after electrochemotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin) * Pregnancy or breastfeeding * Severe comorbidities preventing electrochemotherapy * Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor Microenvironment Biomarker Panel After Electrochemotherapy | Baseline (pre-treatment) and post-treatment (up to 3 months after electrochemotherapy) | Change in a predefined panel of tumor microenvironment biomarkers assessed by histopathology and immunohistochemistry in tumor tissue samples collected before and after electrochemotherapy. Biomarkers include immune cell infiltration markers and vascular markers. Results will be reported separately for each biomarker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Tumor Microenvironment Biomarkers Between Treated and Untreated Lesions | Up to 3 months after electrochemotherapy | Comparison of a predefined panel of tumor microenvironment biomarkers (including immune cell infiltration markers and vascular markers) between electrochemotherapy-treated lesions and untreated lesions in the same patient. |
| Local Tumor Control Rate After Electrochemotherapy | Up to 12 months after electrochemotherapy | Local tumor control of electrochemotherapy-treated cutaneous and subcutaneous melanoma metastases assessed clinically and/or radiologically. |
Countries
Slovenia
Contacts
CONTACTKlavdija Korošec
CONTACTNeža Gros
Outcome results
None listed