Spots Global Cancer Trial Database for Suicide Plus Immune Gene Therapy for Advanced Melanoma

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Trial Identification

Brief Title: Suicide Plus Immune Gene Therapy for Advanced Melanoma

Official Title: Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma

Study ID: NCT03338777

Conditions

Melanoma

Interventions

Suicide plus immunogene therapy

Study Description

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

Detailed 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.