Back to resultsCytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DCIK
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma
Eligibility 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.
Sites / Locations
- Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCIK
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.
Full Information
NCT ID
NCT01240005
First Posted
November 12, 2010
Last Updated
November 12, 2010
Sponsor
Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT01240005
Brief Title
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
Official Title
A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Qingdao University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCIK
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DCIK
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongheng An
Phone
+86-532-82911676
Email
anyongheng@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefeng Zhang
Phone
+86-13789861225
Email
xuefengzhang15@126.com,qdstemcell@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongheng An
Organizational Affiliation
The affilited hospital of medical college,Qingdao university
Official's Role
Study Chair
Facility Information:
Facility Name
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Zhang
Phone
+86-13789861225
Email
xuefengzhang15@126.com,qdstemcell@126.com
First Name & Middle Initial & Last Name & Degree
Yongheng An
Phone
+86-532-82911676
Email
anyongheng@126.com,lyj2001353@163.com
First Name & Middle Initial & Last Name & Degree
Yongheng An
12. IPD Sharing Statement
Learn more about this trial
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
We'll reach out to this number within 24 hrs