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Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01240005
Recruitment Status : Unknown
Verified November 2010 by Qingdao University.
Recruitment status was:  Not yet recruiting
First Posted : November 15, 2010
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
Qingdao University

Brief Summary:

30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.

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.


Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: DCIK Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DCIK Biological: 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.



Primary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Objective tumor response, Time to recurrence, Progression-free, Cellular immunity. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
  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:

  1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240005


Contacts
Contact: Yongheng An +86-532-82911676 anyongheng@126.com
Contact: Xuefeng Zhang +86-13789861225 xuefengzhang15@126.com,qdstemcell@126.com

Locations
China, Shandong
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: Xuefeng Zhang    +86-13789861225    xuefengzhang15@126.com,qdstemcell@126.com   
Contact: Yongheng An    +86-532-82911676    anyongheng@126.com,lyj2001353@163.com   
Principal Investigator: Yongheng An         
Sponsors and Collaborators
Qingdao University
Investigators
Study Chair: Yongheng An The affilited hospital of medical college,Qingdao university

Responsible Party: An Yongheng,Li Yanjiang,Gao Hong,Zhang Xuefeng, The Affilited Hospital of Medical College,Qingdao University
ClinicalTrials.gov Identifier: NCT01240005     History of Changes
Other Study ID Numbers: DCCIK002
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases