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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00862303
• Other study ID #: fuzhough0938
• Secondary ID: fuzhough0938
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 13, 2009
• Last updated: March 7, 2011
• Start date: March 2009
• Est. completion date: December 2015

Study information

• Verified date: March 2009
• Source: Fuzhou General Hospital
• Contact: Jianming Tan, Professor
• Phone: 008613375918000
• Email: TANJM156[@]YAHOO.COM.CN
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• 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.

Drug:
• IL-2/IFN-a
Patients receive treatment of IL-2 or IFN-a.

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.		every 3 months	No
Secondary	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.		at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment	Yes