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

Fuzhou General Hospital100 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Renal Cell Carcinoma

Interventions

DC-CIKBIOLOGICAL

Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.

IL-2/IFN-αDRUG

Patients receive treatment of IL-2 or IFN-α.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fuzhou General Hospital

Fuzhou, Fujian, China

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Jianming Tan, Professor

CONTACT

008613375918000 TANJM156@YAHOO.COM.CN

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.