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

Renal Cell Carcinoma Clinical Trial

Official title:

Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01924156
• Other study ID #: 307-CTC-DC/CIK-RCC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 14, 2013
• Last updated: February 18, 2016
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• adenovirus-transfected DC + CIK
adenovirus-transfected DC vaccine plus CIK cells

Locations

Country	Name	City	State
China	Department of Hematopoietic Stem Cell Transplantation	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective tumor response (CR+PR) as measured by RECIST criteria		4 weeks after DC/CIK treatment	No
Secondary	number of participants with adverse events		3 days within DC/CIK treatment	Yes