Kidney Cancer Clinical Trial
Official title:
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]
RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the
immune system in different ways and stop tumor cells from growing. It is not yet known
whether interleukin-2 given by infusion is more effective than interleukin-2 given by
injection when combined with interferon in treating metastatic kidney cancer.
PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see
how well it works compared to interleukin-2 given by injection when combined with interferon
in treating patients with metastatic kidney cancer.
OBJECTIVES:
Primary
- Compare the overall survival of patients with metastatic renal cell cancer treated with
intravenous vs subcutaneous interleukin-2 in combination with interferon alfa.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare response rates (complete and partial) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive induction therapy comprising interleukin-2 (IL-2) IV
continuously over days 1-5, 15-19, 43-47, and 57-61 (weeks 1, 3, 7, and 9) and
interferon alfa (IFN-α) subcutaneously (SC) three times weekly in weeks 1-3 and 7-9.
Patients then undergo restaging. Patients achieving a complete response (CR), partial
response (PR), or stable disease (SD) then receive maintenance therapy comprising IL-2
IV continuously over 5 days and IFN-α SC three times weekly in weeks 1, 5, 9, and 13.
- Arm II: Patients receive induction therapy comprising IL-2 SC twice daily on days 1-5,
8-12, 15-19, and 22-26 (weeks 1-4). Patients also receive IFN-α SC three times weekly
in weeks 1-4 and 6-9. Patients then undergo restaging. Patients achieving a CR, PR, or
SD then receive maintenance therapy comprising IL-2 SC as in induction therapy and
IFN-α SC three times weekly in weeks 1-4 and 8-11.
Quality of life is assessed at baseline, at the end of induction therapy, and then at the
end of maintenance therapy.
After completion of treatment, patients are followed every 3 months for 2 years and then
every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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