DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma

Phase 1

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: adenovirus-transfected DC + CIK

• Registration Number: NCT01924156
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age >18 years at time of consent
• Histopathologically confirmed diagnosis of renal cell carcinoma
• Received standardized treatment of renal cell carcinoma
• Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
• KPS (Karnofsky performance scale) >60
• Patient's written informed consent
• Predicted survival >3 months
• No severe viral or bacterial infections

Exclusion Criteria

• Receiving chemotherapy, radiotherapy or other therapy
• Patients with other malignancies and infectious diseases
• Pregnant and breast-feeding patient
• Currently participating in another clinical trial
• Unfit for participating in this clinical trial in investigators' opinions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adenovirus-transfected DC + CIK	adenovirus-transfected DC + CIK	adenovirus-transfected autologous DC vaccine plus CIK cells

Primary Outcome Measures

Name	Time	Method
objective tumor response (CR+PR) as measured by RECIST criteria	4 weeks after DC/CIK treatment

Secondary Outcome Measures

Name	Time	Method
number of participants with adverse events	3 days within DC/CIK treatment

Trial Locations

Locations (1)

Department of Hematopoietic Stem Cell Transplantation; 🇨🇳 Beijing, China