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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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

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.


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).


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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Jianming Tan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fuzhou General Hospital


China: Ministry of Health

Study ID:




Start Date:

March 2009

Completion Date:

December 2015

Related Keywords:

  • Renal Cell Carcinoma
  • autologous cytokine induced killer cells
  • dendritic cell
  • vaccine
  • renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell