drugset / Trial / NCT00471133
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
Phase 1
Completed
24 enrolled
Ichor Medical Systems Incorporated
Memorial Sloan Kettering Cancer Center · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pINGmuTyr | Vaccine | 0.2 mg | Intramuscular |
| Subject | pINGmuTyr | Vaccine | 0.5 mg | Intramuscular |
| Subject | pINGmuTyr | Vaccine | 1.5 mg | Intramuscular |