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

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Biological: adenovirus-transfected DC + CIK

Study type: Interventional

Funder types: Other

Identifiers

NCT01924156

307-CTC-DC/CIK-RCC

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

adenovirus-transfected DC + CIK

Experimental group

Description:

adenovirus-transfected autologous DC vaccine plus CIK cells

Treatment:

Biological: adenovirus-transfected DC + CIK