DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating
1 other identifier
interventional
1,200
0 countries
N/A
Brief Summary
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2015
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
July 1, 2015
June 1, 2015
12.9 years
June 24, 2015
June 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free time
3 months
Overall-survival time
3 months
Secondary Outcomes (1)
Objective tumor response
3 months
Study Arms (2)
DC-CIK
EXPERIMENTALPatients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
IL-2/IFN-α
OTHERPatients receive treatment of IL-2 or IFN-α.
Interventions
Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.
Eligibility Criteria
You may qualify if:
- Histologically proven renal cell carcinoma
- Age: \> 18
- WHO- ECOG Performance Status 0-1
- At least one measurable tumor lesions according to the RECIST criteria.
- Life expectancy more than 3 months
- Written informed consent
You may not qualify if:
- Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
- Patients with metastatic disease in the central nervous system (CNS).
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- Patients with acute or chronic infection including HIV.
- Patients who are pregnant or nursing.
- Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
- Patients who receive corticosteroids or other immunosuppressive agents.
- Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 1, 2015
Study Start
August 1, 2015
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2030
Last Updated
July 1, 2015
Record last verified: 2015-06