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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01240005
Other study ID # DCCIK002
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received November 12, 2010
Last updated November 12, 2010
Start date January 2011
Est. completion date September 2013

Study information

Verified date November 2010
Source Qingdao University
Contact Yongheng An
Phone +86-532-82911676
Email anyongheng@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Stem cell cencter of the affiliated hospital of medical colledge,qingdao university Qingdao Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 1 year No
Secondary Objective tumor response, Time to recurrence, Progression-free, Cellular immunity. 1 year No
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