Clinical trial NCT00862303: DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Keywords: autologous cytokine induced killer cells
dendritic cell
vaccine
renal cell carcinoma
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.
timeFrame: every 3 months
Secondary outcomes:
measure: 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.
timeFrame: at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: