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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
Sponsor:
Information provided by:
Fuzhou General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: DC-CIK Drug: IL-2/IFN-α Phase 1 Phase 2

Detailed Description:

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

  1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
  2. Determine safety of multiple administrations of this regimens in these patients.
Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jianming Tan, Professor 008613375918000 TANJM156@YAHOO.COM.CN

Locations
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China, Fujian
Fuzhou General Hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Jianming Tan, M.D and Ph.D    008613375918000    TANJM156@YAHOO.COM.CN   
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
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Principal Investigator: Jianming Tan, M.D. Fuzhou General Hospital
More Information
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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
Keywords provided by Fuzhou General Hospital:
autologous cytokine induced killer cells
dendritic cell
vaccine
renal cell carcinoma
Additional relevant MeSH terms:
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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