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Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response

Melanoma Clinical Trial

Official title:
Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response

Clinical Trial Summary

The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse TYRP2 in patients with melanoma. DNA is a material that contains the information needed to produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps to produce their black color. The DNA used in this study is the gene for mouse TYRP2.

The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is then made from bacteria that is inactive.

We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA. We will also follow the patients closely to see if there are any side effects. Mouse TYRP2 DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T cells) that recognize melanoma cells. Antibodies are substances produced by your immune system to defend your body against bacteria and viruses. T cells are a type of white blood cell that can also fight infections. The small differences between mouse and human TYRP2 may allow your immune system to make the antibodies and T cells against melanoma. There is no evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00680589
Study type Interventional
Source Memorial Sloan Kettering Cancer Center
Contact
Status Completed
Phase Phase 1
Start date July 2006
Completion date March 2011
View Details
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