Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
NCT ID: NCT01240005
Last Updated: 2010-11-15
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
30 participants
INTERVENTIONAL
2011-01-31
2013-09-30
Brief Summary
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Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.
The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCIK
DCIK
Renal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed.
Interventions
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DCIK
Renal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of renal cell carcinoma.
3. Newly diagnosed or recurrent disease.
4. Karnofsky performance status 60-100.
5. Life expectancy ≥ 12 weeks.
6. Written informed consent of patient and/or legal guardian.
7. Must be off steroid at least two weeks prior to vaccination.
8. Hematologic and metabolic panel results will be within the parameters of the protocol.
9. Normal renal function in the kidney.
10. Adequate function of liver,lung and heart.
11. Negative pregnancy test
12. Fertile patients must use effective contraception
13. Serologically negative for HIV,HBV,HCV.
14. Syphilis serology negative
15. Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
Exclusion Criteria
2. Presence of acute infection.
3. Inability to obtain informed consent because of psychiatric or complicating medical problems.
4. Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
5. Subjects with organ allografts.
6. Known history of autoimmune disorder.
7. Pregnancy or breast-feeding.
8. Positive for hepatitis B, C, HIV, syphilis.
9. Patients unwilling to perform a save method of birth control.
18 Years
75 Years
ALL
No
Sponsors
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Qingdao University
OTHER
Responsible Party
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The Affilited Hospital of Medical College,Qingdao University
Principal Investigators
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Yongheng An
Role: STUDY_CHAIR
The affilited hospital of medical college,Qingdao university
Locations
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Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Xuefeng Zhang
Role: primary
Yongheng An
Role: backup
Other Identifiers
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DCCIK002
Identifier Type: -
Identifier Source: org_study_id