Last reviewed · How we verify
A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
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.
Details
| Lead sponsor | Ichor Medical Systems Incorporated |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2007-04 |
| Completion | 2010-05 |
Conditions
- Melanoma (Skin)
- Intraocular Melanoma
Interventions
- Xenogeneic Tyrosinase DNA Vaccine
- TriGrid Delivery System for Intramuscular Electroporation
Primary outcomes
- Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma. — one year
Countries
United States