Status:
UNKNOWN
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
Lead Sponsor:
Qingdao University
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01240005
Start Date
January 1 2011
End Date
September 1 2013
Last Update
November 15 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, China, 266000