Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
- A secondary endpoint is to observe the patients for evidence of any antitumor response generated after immunizations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Injection of mouse TYRP2 DNA in patients with highrisk melanoma.
Biological: injection of mouse TYRP2 DNA
Cohorts of three patients will receive injections with mouse TYRP2 DNA delivered intramuscularly at four different dose levels (500, 2000, 4000 or 8000 μg) every three weeks for six injections.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jedd Wolchok, MD||Memorial Sloan-Kettering Cancer Center|