Melanoma Clinical Trial
Official title:
Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
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.
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