DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating
NCT ID: NCT02487550
Last Updated: 2015-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
1200 participants
INTERVENTIONAL
2015-08-31
2030-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DC-CIK
Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
DC-CIK
Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
IL-2/IFN-α
Patients receive treatment of IL-2 or IFN-α.
IL-2/IFN-α
Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.
Interventions
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DC-CIK
Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
IL-2/IFN-α
Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Changzhou
OTHER
Responsible Party
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xiaodong li
Principal Investigator
Other Identifiers
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CIKRC001
Identifier Type: -
Identifier Source: org_study_id
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