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About
RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer.
PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at the end of induction therapy, and then at the end of maintenance therapy.
After completion of treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic renal cell adenocarcinoma
Nephrectomized
Measurable or evaluable disease
No brain metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 90-100%
Hematocrit ≥ 30%
WBC ≥ 4,000/mm^3
Platelet count ≥ 120,000/mm^3
Bilirubin normal
Creatinine ≤ 1.7 mg/dL
FEV_1 ≥ 50%
No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following:
No active infections requiring antibiotic treatment
No severe neuropsychiatric condition
No geographical, psychological, or familial conditions that would preclude study treatment
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
LVEF ≥ 50%
No severe autoimmune disease
No known chronic hepatitis
No HIV positivity
No hepatitis B surface antigen positivity
No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix
No severe pulmonary, hepatic, or renal condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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