drugset / Trial / NCT00458536

Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

NCT00458536

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Timeline

Start
2004-10
Primary completion
2014-12
Completion
2023-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dendritic Cell Tumor Fusion Vaccine Vaccine Subcutaneous
Subject sargramostim Protein / enzyme biologic

Indications