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
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Biological: DCIK
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response, Time to recurrence, Progression-free, Cellular immunity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014