NCT01924156
Unknown
Phase 1
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
Affiliated Hospital to Academy of Military Medical Sciences1 site in 1 country30 target enrollmentJuly 2013
ConditionsRenal Cell Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- objective tumor response (CR+PR) as measured by RECIST criteria
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
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(3 days within DC/CIK treatment)
Study Sites (1)
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