DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma

• ClinicalTrials.gov Identifier: NCT00862303
• Recruitment Status: Unknown
• First Posted: March 16, 2009
• Last Update Posted: March 8, 2011
• Sponsor: Fuzhou General Hospital
• Information provided by: Fuzhou General Hospital

Tracking Information

• First Submitted Date: March 13, 2009
• First Posted Date: March 16, 2009
• Last Update Posted Date: March 8, 2011
• Study Start Date: March 2009
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 13, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 13, 2009): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Cell Carcinoma

Intervention

• 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
• Drug: IL-2/IFN-α
  Patients receive treatment of IL-2 or IFN-α.
  Other Name: 2

Study Arms

• Placebo Comparator: IL-2/IFN-α
  Intervention: Drug: IL-2/IFN-α
• Experimental: DC-CIK
  Intervention: Biological: DC-CIK

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 13, 2009): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00862303
• Other Study ID Numbers: fuzhough0938; fuzhough0938
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Fuzhou General Hospital
• Study Sponsor: Fuzhou General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jianming Tan, M.D.; Fuzhou General Hospital

• PRS Account: Fuzhou General Hospital
• Verification Date: March 2009