DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT00862303|
Recruitment Status : Unknown
Verified March 2009 by Fuzhou General Hospital.
Recruitment status was: Recruiting
First Posted : March 16, 2009
Last Update Posted : March 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Biological: DC-CIK Drug: IL-2/IFN-α||Phase 1 Phase 2|
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 regime.
1. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).
- Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
- Determine safety of multiple administrations of this regimens in these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2015|
|Placebo Comparator: IL-2/IFN-α||
Patients receive treatment of IL-2 or IFN-α.
Other Name: 2
Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
Other Name: 1
- Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria. [ Time Frame: every 3 months ]
- Immunity as measured by T-cell functionality (immuknow assay )to the tumor. Safety as measured by NCI common toxicity table （CTC） at completion of study. [ Time Frame: at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862303
|Contact: Jianming Tan, Professor||008613375918000||TANJM156@YAHOO.COM.CN|
|Fuzhou General Hospital||Recruiting|
|Fuzhou, Fujian, China, 350025|
|Contact: Jianming Tan, M.D and Ph.D 008613375918000 TANJM156@YAHOO.COM.CN|
|Principal Investigator:||Jianming Tan, M.D.||Fuzhou General Hospital|