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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
OBJECTIVES: Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8. Arm II (control arm): Patients receive no adjuvant treatment before disease progression. Quality of life is assessed at baseline and at 2 and 6 months after randomization. Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.

Official Title
-----------------
Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Biological: aldesleukin
* Biological: recombinant interferon alfa
* Drug: fluorouracil
* Procedure: adjuvant therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: recombinant interferon alfa|nan|
|Drug: fluorouracil|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage III renal cell cancer, stage IV renal cell cancer