drugset / Trial / NCT00053807

Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer

NCT00053807

RandomizedTreatment

Summary

RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.

Timeline

Start
1998-02
Primary completion
2004-01
Completion

Publications

  • Results Aitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell carcinoma (RCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-4505, 2011.

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic Subcutaneous
Subject fluorouracil Small molecule Intravenous
Subject interferon alfa-2b Protein / enzyme biologic Subcutaneous

Indications