NCT00862303

DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma

Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

Detailed description

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime. Primary 1\. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK). Secondary 1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen. 2. Determine safety of multiple administrations of this regimens in these patients.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	DC-CIK	Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
DRUG	IL-2/IFN-α	Patients receive treatment of IL-2 or IFN-α.

Timeline

• Start date: 2009-03-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2009-03-16
• Last updated: 2011-03-08

Locations

1 site across 1 country: China