Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
NCT00053820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670
Last updated 2013-12-19
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 with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.
Conditions
Interventions
- BIOLOGICAL
-
aldesleukin
- BIOLOGICAL
-
recombinant interferon alfa
- DRUG
Sponsors & Collaborators
-
European Organisation for Research and Treatment of Cancer - EORTC
collaborator NETWORK - lead OTHER_GOV
Principal Investigators
-
Martin E. Gore, MD · Royal Marsden NHS Foundation Trust
-
Peter F.A. Mulders, MD, PhD · Universitair Medisch Centrum St. Radboud - Nijmegen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Max Age
- 81 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-07-31
- Completion
- 2006-12-31
Countries
- Belgium
- Germany
- Netherlands
- Slovakia
Study Locations
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