NCT00698100

Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines

Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines: A Phase I Trial to Assess Safety and Immune Response

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.

Conditions

• Melanoma
• Skin

Interventions

Type	Name	Description
BIOLOGICAL	human tyrosinase	Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
BIOLOGICAL	mouse tyrosinase	Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase

Timeline

• Start date: 2002-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-06-16
• Last updated: 2011-09-16

Locations

1 site across 1 country: United States