A Phase 3 interventional study of aldesleukin and recombinant interferon alfa in Kidney Cancer, sponsored by Medical Research Council. Completed at 12 sites in 4 countries. Open to participants aged 18 Years to 81 Years. Per ClinicalTrials.gov, last updated 2013-12-19.
Sponsored by Medical Research Council · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.
Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 670 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Medical Research Council is the lead sponsor of 67 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Survival
Time to progression as measured by RECIST criteria
Comparison of toxicity levels (Grade III and IV)
Comparison of quality of life before, during, after completion of study treatment
Impact of the treatment regimens on health economics
This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.
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Medical Research Council