Kidney Cancer Clinical Trial
Official title:
A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body
build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's
lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of
cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more
tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
interleukin-2 and interferon alfa works in treating patients with metastatic renal cell
carcinoma (kidney cancer).
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with metastatic renal cell carcinoma
treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC
vaccine) in combination with interleukin-2 and interferon-alfa.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine, within relevant immune pathways, the treatment-related, tumor-specific immune
response in patients treated with this regimen.
- Correlate tumor-specific immune response with objective clinical response in patients
treated with this regimen.
OUTLINE:
- Induction therapy: Patients undergo leukapheresis on day -9. Patients receive autologous
dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by intranodal
injection on days 0 and 14; interleukin-2 (IL-2) IV continuously on days 1-5 and 15-19;
and interferon-alfa (IFN-α) subcutaneously (SC) once daily on days 1, 3, 5, 15, 17, and
19.
- Maintenance therapy: Patients undergo leukapheresis on days 33, 61, and 89. Patients
receive DC vaccine by intranodal injection on days 42, 70, and 98; IL-2 IV continuously
on days 43-47, 71-75, and 99-103; and IFN-α SC once daily on days 43, 45, 47, 71, 73,
75, 99, 101, and 103.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
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