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

Phase 1

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: DCIK

• Registration Number: NCT01240005
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Last Update Submitted: 2010-11-12
• Study First Posted: 2010-11-15
• Last Update Posted: 2010-11-15
• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCIK	DCIK	-

Primary Outcome Measures

Name	Time	Method
overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.	1 year

Trial Locations

Locations (1)

Stem cell cencter of the affiliated hospital of medical colledge,qingdao university; 🇨🇳 Qingdao, Shandong, China