DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
NCT ID: NCT00862303
Last Updated: 2011-03-08
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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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2009-03-31
2015-12-31
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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IL-2/IFN-α
IL-2/IFN-α
Patients receive treatment of IL-2 or IFN-α.
DC-CIK
DC-CIK
Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
Interventions
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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.
IL-2/IFN-α
Patients receive treatment of IL-2 or IFN-α.
Other Intervention Names
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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
ALL
No
Sponsors
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Fuzhou General Hospital
OTHER
Responsible Party
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Fuzhou General Hospital
Principal Investigators
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Jianming Tan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fuzhou General Hospital
Locations
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Fuzhou General Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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fuzhough0938
Identifier Type: -
Identifier Source: secondary_id
fuzhough0938
Identifier Type: -
Identifier Source: org_study_id
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