NCT00471133

Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ichor Medical Systems Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.

Detailed description

This study is designed to evaluate administration of a xenogeneic DNA vaccine encoding the melanosomal antigen tyrosinase by in vivo electroporation in patients with malignant melanoma. The objectives of the study are to characterize the safety and immunogenicity of a DNA vaccine encoding the murine tyrosinase gene delivered administered intramuscularly using the electroporation based TriGrid Delivery System (Ichor Medical Systems). We will assess the nature, frequency, and severity of any toxicity associated with vaccination at escalating pINGmuTyr doses and then expand enrollment at then expand enrollment at the Maximum Tolerated Dose to assess immunologic responses to the tyrosinase antigen. The hypotheses being tested are that the procedure is feasible and safe and that it induces immune responses specific for tyrosinase in patients with stage IIB-IV malignant melanoma.

Conditions

• Melanoma (Skin)
• Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Xenogeneic Tyrosinase DNA Vaccine
DEVICE	TriGrid Delivery System for Intramuscular Electroporation

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-05-09
• Last updated: 2011-06-07

Locations

1 site across 1 country: United States