NCT02487550

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 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 Neoplasma

Interventions

Type	Name	Description
BIOLOGICAL	DC-CIK	Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
BIOLOGICAL	IL-2/IFN-α	Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.

Timeline

• Start date: 2015-08-01
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2015-07-01
• Last updated: 2015-07-01