Who is sponsoring NCT00458536?

NCT00458536 is sponsored by Beth Israel Deaconess Medical Center.

What condition does NCT00458536 study?

NCT00458536 studies Renal Cancer.

What drugs are being tested in NCT00458536?

Interventions: Dendritic Cell Tumor Fusion Vaccine, Granulocyte Macrophage Colony Stimulating Factor (GM-CSF).

What is the status of NCT00458536?

NCT00458536 is currently COMPLETED.

Last reviewed 2026-01-21 · How we verify

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

NCT00458536 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	38
Start date	2004-10
Completion	2023-07

Conditions

Renal Cancer

Interventions

Dendritic Cell Tumor Fusion Vaccine
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Primary outcomes

Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF — 5 years

Countries

United States