NCT00416871

Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer

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]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	recombinant interferon alfa

Timeline

• Completion: 2006-02-01
• First posted: 2006-12-28
• Last updated: 2012-09-26