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

• Status: Completed
• Trial end date: 1969-12-31
• 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 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.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:

• Stage T3b, T3c, or T4 tumor

• Any pT stage and nodal status pN 1 or 2

• Any pT stage and microscopic positive margins

• Presence of any microscopic vascular invasion

• Underwent surgical resection of primary tumor within the past month

• Removal of clinical N+ disease required

• No evidence of metastatic disease

• No evidence of macroscopic residual disease

PATIENT CHARACTERISTICS:

Age

• 75 and under

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Liver function tests no greater than 1.25 times upper limit of normal (ULN)

Renal

• Creatinine less than 1.5 times ULN

Cardiovascular

• No myocardial infarction within the past 6 months

• No unstable angina pectoris

Other

• Not pregnant or nursing

• No prior or other concurrent malignancies that would preclude study therapy or comparisons

• No other concurrent illness that would preclude study therapy

• No concurrent active infections requiring antibiotic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No concurrent corticosteroids

• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

• No prior major organ allografts

Other

• No other concurrent investigational drugs, agents, or devices