20.500.12556/DiRROS-19762 Treatment of skin tumors with intratumoral interleukin 12 gene electrotransfer in the head and neck region a first-in-human clinical trial protocol Immune therapies are currently under intensive investigation providing in many cases excellent re-sponses in different tumors. Other possible approach for immunotherapy is a targeted intratumoral delivery of inter-leukin 12 (IL-12), a cytokine with anti-tumor effectiveness. Due to its immunomodulatory action, it can be used as an imunostimulating component to in situ vaccinating effect of local ablative therapies. We have developed a phIL12 plasmid devoid of antibiotic resistance marker with a transgene for human IL-12 p70 protein. The plasmid can be delivered intratumorally by gene electrotransfer (GET). Patients and methods. Here we present a first-in-human clinical trial protocol for phIL12 GET (ISRCTN15479959, ClinicalTrials NCT05077033). The study is aimed at evaluating the safety and tolerability of phIL12 GET in treatment of basal cell carcinomas in patients with operable tumors in the head and neck region. The study is designed as an ex-ploratory, dose escalating study with the aim to determine the safety and tolerability of the treatment and to identify the dose of plasmid phIL12 that is safe and elicits its biological activity. Conclusions. The results of this trail protocol will therefore provide the basis for the use of phIL12 GET as an adjuvant treatment to local ablative therapies, to potentially increase their local and elicit a systemic response. skin tumors gene electrotransfer interleukin 12 clinical trial rak kože elektroprenos genov interlevkin 12 klinično preizkušanje true false true Association of Radiology and Oncology Ljubljana Angleški jezik Slovenski jezik by Authors Neznano 2024-07-24 14:48:03 2024-07-24 14:48:03 2024-07-26 03:52:57 0000-00-00 00:00:00 2022 0 0 str. 398-408 no. 3 Vol. 56 2022 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 2022-01-01 602.64:616.22-006 1318-2099 10.2478/raon-2022-0021 107217411 RAZ_Groselj_Ales_2022.pdf RAZ_Groselj_Ales_2022.pdf 1 C8473896E580080C8A1E8425154F71D7 a7f448d06006be7bafead21d3c44be62f6f9ce6d61ba553d881d377401614134 5c83216b-49aa-11ef-b487-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=27359 Onkološki inštitut Ljubljana 0 0 0