Basal cell carcinoma, squamous cell carcinoma, melanoma or metastases of adenocarcinoma of the breast, treated with electrochemotherapy Cancer Malignant neoplasm of breast
Conditions
Interventions
All patients are treated with electrochemotherapy with bleomycin (BLM), according to European Standard Operating Procedures of Electrochemotherapy. Bleomycin will be injected intravenously in a dose o
Sponsors
Department of Otorhinolaryngology and Cervicofacial Surgery University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligible for electrochemotherapy of cutaneous tumors (basal cell carcinoma, squamous cell carcinoma, melanoma) and cutaneus metastases of melanoma and adenocarcinoma of the breast 2. Age =18 years 3. Agree to participate in this study and signed informed consent
Exclusion criteria
Exclusion criteria: 1. Do not comply with requirements for the blood collection, or samples were not collected according to the SOP for blood collection 2. Do not comply with the requirements for tumor biopsy, or samples were not collected according to the SOP for tissue sampling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics of bleomycin assessed by: 1. Collection of patient’s sera undergoing electrochemotherapy according to the SOP (5, 10, 20 and 30 min after ECT) and in compliance with the NICE recommendations for determination of in vivo BLM pharmacokinetics. 2. Collection of tumor tissue of the same patients at the time of application of electric pulses (8 min after intravenous 15 000 IU/m2 BLM injection) for determination of BLM concentration in treated tumors. | — |
Countries
Hungary, Slovenia
Outcome results
None listed