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

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC-CIK
IL-2/IFN-α
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring autologous cytokine induced killer cells, dendritic cell, vaccine, renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuzhou General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

IL-2/IFN-α

DC-CIK

Arm Description

Outcomes

Primary Outcome Measures

Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.

Secondary Outcome Measures

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.

Full Information

First Posted
March 13, 2009
Last Updated
March 7, 2011
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00862303
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
autologous cytokine induced killer cells, dendritic cell, vaccine, renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IL-2/IFN-α
Arm Type
Placebo Comparator
Arm Title
DC-CIK
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Other Intervention Name(s)
1
Intervention Description
Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
Intervention Type
Drug
Intervention Name(s)
IL-2/IFN-α
Other Intervention Name(s)
2
Intervention Description
Patients receive treatment of IL-2 or IFN-α.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Tan, Professor
Phone
008613375918000
Email
TANJM156@YAHOO.COM.CN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, M.D.
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, M.D and Ph.D
Phone
008613375918000
Email
TANJM156@YAHOO.COM.CN

12. IPD Sharing Statement

Learn more about this trial

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

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