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

Renal Neoplasma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02487550
• Other study ID #: CIKRC001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 24, 2015
• Last updated: June 29, 2015
• Start date: August 2015
• Est. completion date: July 2030

Study information

• Verified date: June 2015
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• 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: Not yet recruiting
• Enrollment: 1200
• Est. completion date: July 2030
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

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, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Neoplasma

Intervention

Biological:
• DC-CIK
Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
• IL-2/IFN-a
Patients with renal cell carcinoma will receive IL-2/IFN-a by venous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free time		3 months	No
Primary	Overall-survival time		3 months	No
Secondary	Objective tumor response		3 months	No