DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating

Soochow University

Status and phase: Not yet enrolling; Phase 2

Conditions: Renal Neoplasma

Treatments: Biological: DC-CIK; Biological: IL-2/IFN-α

Study type: Interventional

Funder types: Other

Identifiers

NCT02487550

CIKRC001

Details and patient eligibility

About

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

Full description

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.

Primary

1. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).

Secondary

1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
2. Determine safety of multiple administrations of this regimens in these patients.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven renal cell carcinoma
• Age: > 18
• WHO- ECOG Performance Status 0-1
• At least one measurable tumor lesions according to the RECIST criteria.
• Life expectancy more than 3 months
• Written informed consent

Exclusion criteria

• Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
• Patients with metastatic disease in the central nervous system (CNS).
• Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
• Patients with acute or chronic infection including HIV.
• Patients who are pregnant or nursing.
• Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
• Patients who receive corticosteroids or other immunosuppressive agents.
• Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

DC-CIK

Experimental group

Description:

Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.

Treatment:

Biological: DC-CIK

IL-2/IFN-α

Other group

Description:

Patients receive treatment of IL-2 or IFN-α.

Treatment:

Biological: IL-2/IFN-α