A Phase 1 interventional study of phIL12 GET in Basal Cell Carcinoma, sponsored by Institute of Oncology Ljubljana. Completed at 2 sites in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Institute of Oncology Ljubljana · Phase 1, Interventional, and Treatment
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.
369 studies on the registry are indexed under Carcinoma, Basal Cell; 65 are open to participants now.
This study's enrollment of 9 is below the median of 41 across 262 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Institute of Oncology Ljubljana is the lead sponsor of 90 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Drug: phIL12 GET
intratumoral phIL12 gene electrotransfer
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.
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Institute of Oncology Ljubljana