NCT03338777

Suicide Plus Immune Gene Therapy for Advanced Melanoma

Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Suicide plus immunogene therapy	1. Intra and peritumoral infiltrates with multiple injections of 0.1 ml/cm2 or 0.2 ml/cm3 of lipoplexes bearing the HSVtk suicide gene (1: 1; 1 mg/ml, according to tumor size), co-administered with GCV (12.5 mg/ml). Patients start with a minimum of 0.5 ml and at the 3rd week, the maximum dose is scaled according to the tumor size up to 2 ml maximum. 2. Treated simultaneously with a subcutaneous vaccine produced with: * Formolized allogeneic tumor extracts and, * Lipoplexes carrying hIL-2 and hGM-CSF genes (0.5 mg each).

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2017-11-09
• Last updated: 2020-02-25

Locations

1 site across 1 country: Argentina