Last updated on February 2018

Suicide Plus Immune Gene Therapy for Advanced Melanoma

Brief description of study

Safety evaluation of combined immunogene therapy in patients with advanced melanoma.

Detailed Study Description

This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.

This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.

The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes.

Clinical Study Identifier: NCT03338777

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Hospital Italiano

Ciudad Autónoma de Buenos Aires, Argentina
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