Spots Global Cancer Trial Database for Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells

Official Title: Phase I Study of Active Immunotherapy of Metastatic Melanoma With Mature Autologous Dendritic Cells Transfected With Tumor Antigen RNA and Small Inhibitory RNAs to Alter Proteasomal Antigen Processing

Study ID: NCT00672542

Conditions

Metastatic Melanoma

Absence of CNS Metastases

Interventions

Proteasome siRNA and tumor antigen RNA-transfected dendritic cells

Study Description

Brief Summary: Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based on preclinical results, will induce enhanced anti-melanoma immune responses. This phase I study, open to subjects with metastatic melanoma, will assess the safety of vaccination with melanoma tumor associated antigen-encoding RNA-transfected mature dendritic cells derived from monocytes that have been either untreated, transfected with control siRNA, or transfected with siRNA targeting the inducible immunoproteasome beta subunits LMP2, LMP7, and MECL1. A combination of RNAs encoding melanoma tumor associated antigens MART-1, tyrosinase, gp100, and MAGE-3 will be utilized for dendritic cell transfection. The vaccine will be administered by intradermal injection in the extremities. Clinical and laboratory toxicities will be characterized for each study arm. As a secondary objective, this phase I study will also assess the anti-melanoma immune responses, as well as clinical responses, induced by vaccination with this dendritic cell-based product.

Detailed Description: