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
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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.
Primary
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).
Secondary
- 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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: IL-2/IFN-α |
Drug: IL-2/IFN-α
Patients receive treatment of IL-2 or IFN-α.
Other Name: 2 |
Experimental: DC-CIK |
Biological: DC-CIK
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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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 |
China, Fujian | |
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 |
Responsible Party: | Fuzhou General Hospital |
ClinicalTrials.gov Identifier: | NCT00862303 |
Other Study ID Numbers: |
fuzhough0938 fuzhough0938 |
First Posted: | March 16, 2009 Key Record Dates |
Last Update Posted: | March 8, 2011 |
Last Verified: | March 2009 |
autologous cytokine induced killer cells dendritic cell vaccine renal cell carcinoma |
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |