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

Last updated: March 7, 2011
Sponsor: Fuzhou General Hospital
Overall Status: Trial Status Unknown

Phase

1/2

Condition

Renal Cell Carcinoma

Cancer/tumors

Carcinoma

Treatment

N/A

Clinical Study ID

NCT00862303
fuzhough0938
fuzhough0938
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 carcinomasof the skin).

  • Patients with metastatic disease in the central nervous system (CNS).

  • Patients with other significant illness including severe allergy, asthma, anginapectoris 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 orimmunotherapy 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, rheumatoidarthritis or thyroiditis.

Study Design

Total Participants: 100
Study Start date:
March 01, 2009
Estimated Completion Date:
December 31, 2015

Study 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.

Connect with a study center

  • Fuzhou General Hospital

    Fuzhou, Fujian 350025
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.