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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2009 by Fuzhou General Hospital
Sponsor:
Information provided by:
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT00862303
First received: March 13, 2009
Last updated: March 7, 2011
Last verified: March 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

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. [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

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. [ Time Frame: at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862303

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

Locations
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
Principal Investigator: Jianming Tan, M.D. Fuzhou General Hospital
  More Information

No publications provided

Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT00862303     History of Changes
Other Study ID Numbers: fuzhough0938, fuzhough0938
Study First Received: March 13, 2009
Last Updated: March 7, 2011
Health Authority: China: Ministry of Health

Keywords provided by Fuzhou General Hospital:
autologous cytokine induced killer cells
dendritic cell
vaccine
renal cell carcinoma

Additional relevant MeSH terms:
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
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014