Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Collaborator: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Aldesleukin; Fluorouracil; Interferon-alpha; Interferons; Interleukin-2

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Advanced metastatic disease that requires treatment

• Measurable disease (single bone lesions not included)

• No brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 to 81

Performance status

• WHO 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC greater than 3,000/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 10 g/dL

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No myocardial infarction within the past 6 months

• No unstable angina pectoris

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for at least 6 months after study participation

• No other concurrent disease or prior malignancy that would preclude study treatments or comparisons

• No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No prior endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• Prior resection of the primary tumor recommended but not required

• No prior major organ allografts