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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Qingdao University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01240005
First received: November 12, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 12, 2010
November 12, 2010
January 2011
December 2012   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
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.
Experimental: DCIK
Intervention: Biological: DCIK
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
September 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Yongheng An +86-532-82911676 anyongheng@126.com
Contact: Xuefeng Zhang +86-13789861225 xuefengzhang15@126.com,qdstemcell@126.com
China
 
NCT01240005
DCCIK002
No
An Yongheng,Li Yanjiang,Gao Hong,Zhang Xuefeng, The Affilited Hospital of Medical College,Qingdao University
Qingdao University
Not Provided
Study Chair: Yongheng An The affilited hospital of medical college,Qingdao university
Qingdao University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP