This trial is active, not recruiting.

Condition renal cell carcinoma
Treatment adenovirus-transfected dc + cik
Phase phase 1/phase 2
Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Start date July 2013
End date December 2016
Trial size 30 participants
Trial identifier NCT01924156, 307-CTC-DC/CIK-RCC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
adenovirus-transfected autologous DC vaccine plus CIK cells
adenovirus-transfected dc + cik
adenovirus-transfected DC vaccine plus CIK cells

Primary Outcomes

objective tumor response (CR+PR) as measured by RECIST criteria
time frame: 4 weeks after DC/CIK treatment

Secondary Outcomes

number of participants with adverse events
time frame: 3 days within DC/CIK treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Hu Chen, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Affiliated Hospital to Academy of Military Medical Sciences.