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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
intratumoral phIL12 gene electrotransfer
Institute of Oncology Ljubljana
Ljubljana, Slovenia
University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial Surgery
Ljubljana, Slovenia
Number of acute adverse events
CTCAE v.5.0 criteria
Time frame: Adverse events 2 days after the treatment.
Number of adverse events 7 days after the treatment
CTCAE v.5.0 criteria
Time frame: Adverse events 7 days after the treatment.
Number of late adverse events
CTCAE v.5.0 criteria
Time frame: Adverse events 30 days after the treatment.
Evaluating quality of life with questionnaire one week after the treatment
EORTC QLQ-C30
Time frame: Changes from baseline 7 days after the treatment.
Evaluating quality of life with questionnaire one month after the treatment
EORTC QLQ-C30
Time frame: Changes from baseline 30 days after the treatment.
Area under the plasma concentration versus time curve (AUC)
Determination of serum levels of IL-12 cytokine.
Time frame: Changes from baseline at 2, 7 and 30 days after the treatment.
Concentrations of IL-12 and IFN-y in tumor samples
Determination of tumor IL-12 and IFN-y levels in tumor biopsies.
Time frame: Changes from baseline at 7 and 30 days after the treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.