drugset / Trial / NCT00416871

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

NCT00416871 ↗

Phase 3 Completed 220 enrolled Centre Leon Berard
RandomizedOpen-labelTreatment

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.

Timeline

Start
—
Primary completion
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Completion
2006-02

Outcome

Missed primary endpoint

paper Overall survival difference was not significant: median 33 months (95% confidence interval, 27.0-40.2; P = 0.202). PMID 18794104 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 9e+06 iu Intravenous
Subject aldesleukin Protein / enzyme biologic 1.8e+07 iu Intravenous
Subject aldesleukin Protein / enzyme biologic 1.8e+07 iu/kg Intravenous
Subject recombinant interferon alfa Protein / enzyme biologic 6e+06 iu Subcutaneous

Indications