Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
This study is not yet open for participant recruitment.
Verified November 2010 by Qingdao University
Sponsor:
Qingdao University
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
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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:
- Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
- Histologically confirmed diagnosis of renal cell carcinoma.
- Newly diagnosed or recurrent disease.
- Karnofsky performance status 60-100.
- Life expectancy ≥ 12 weeks.
- Written informed consent of patient and/or legal guardian.
- Must be off steroid at least two weeks prior to vaccination.
- Hematologic and metabolic panel results will be within the parameters of the protocol.
- Normal renal function in the kidney.
- Adequate function of liver,lung and heart.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Serologically negative for HIV,HBV,HCV.
- Syphilis serology negative
- Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
Exclusion Criteria:
- Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study.
- Presence of acute infection.
- Inability to obtain informed consent because of psychiatric or complicating medical problems.
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- Subjects with organ allografts.
- Known history of autoimmune disorder.
- Pregnancy or breast-feeding.
- Positive for hepatitis B, C, HIV, syphilis.
- Patients unwilling to perform a save method of birth control.
Contacts and Locations
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 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 |
ClinicalTrials.gov processed this record on May 16, 2013