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

NCT ID: NCT00862303

Last Updated: 2011-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IL-2/IFN-α

Group Type PLACEBO_COMPARATOR

IL-2/IFN-α

Intervention Type DRUG

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

DC-CIK

Group Type EXPERIMENTAL

DC-CIK

Intervention Type BIOLOGICAL

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

Interventions

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DC-CIK

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

Intervention Type BIOLOGICAL

IL-2/IFN-α

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

Intervention Type DRUG

Other Intervention Names

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1 2

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fuzhou General Hospital

Principal Investigators

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Jianming Tan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital

Locations

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Fuzhou General Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianming Tan, Professor

Role: CONTACT

008613375918000

Facility Contacts

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Jianming Tan, M.D and Ph.D

Role: primary

008613375918000

Other Identifiers

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fuzhough0938

Identifier Type: -

Identifier Source: secondary_id

fuzhough0938

Identifier Type: -

Identifier Source: org_study_id

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