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

Study Overview
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Brief Summary
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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.

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

Official Title
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Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Biological: DC-CIK
* Drug: IL-2/IFN-α


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: IL-2/IFN-α<br> | Drug: IL-2/IFN-α<br>* Patients receive treatment of IL-2 or IFN-α.<br>* Other names: 2;|
| Experimental: DC-CIK<br> | Biological: DC-CIK<br>* Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.<br>* Other names: 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria. |  | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunity as measured by T-cell functionality (immuknow assay )to the tumor. Safety as measured by NCI common toxicity table （CTC） at completion of study. |  | at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous cytokine induced killer cells, dendritic cell, vaccine, renal cell carcinoma