Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements. In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.
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Number of acute adverse events
Timeframe: Adverse events 2 days after the treatment.
Number of adverse events 7 days after the treatment
Timeframe: Adverse events 7 days after the treatment.
Number of late adverse events
Timeframe: Adverse events 30 days after the treatment.
Evaluating quality of life with questionnaire one week after the treatment
Timeframe: Changes from baseline 7 days after the treatment.
Evaluating quality of life with questionnaire one month after the treatment
Timeframe: Changes from baseline 30 days after the treatment.