Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aldesleukin; recombinant interferon alfa
Intervention type(s): Biological; Biological
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer