Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer

Inclusion criteria

DISEASE CHARACTERISTICS: * Documented histologically confirmed metastatic renal cell carcinoma * Clear cell histology * Disease must be measurable as defined by lesions that can be accurately measured in at least one dimension with longest diameter \> 20 mm using conventional techniques or \> 10 mm with spiral CT scan * Must have at least one measurable lesion * If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology * Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes) * The following are considered nonmeasurable lesions: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Cystic lesions * Abdominal masses not confirmed and followed by imaging techniques * No CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status \< 2 * Life expectancy of at least 4 months * Serum creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min * Total bilirubin normal * Platelets \> 100,000/mm³ * WBC \> 3,500/mm³ * No evidence of congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms are present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study) * Adequate pulmonary reserve * Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment * FEV\_1 \> 2.0 liters of \> 75% predicted for height and age * Patients unable to perform PFTs will be excluded * Women who are pregnant or lactating are not eligible * Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study * Negative pregnancy test * No known HIV-positive patients * No evidence of active infection requiring antibiotic therapy * Must not have a contraindication to treatment with pressor agents * Must not have any significant medical disease that, in the opinion of the investigator, may interfere with completion of the study * No history of another malignancy within the past 5 years other than basal cell skin cancer PRIOR CONCURRENT THERAPY: * Recovered from all toxic effects of prior therapy * Must not currently receive chronic medication for asthma * No prior interleukin-2 (IL-2) therapy * No prior organ allografts * No systemic corticosteroids in the 4 weeks prior to treatment * No concurrent systemic steroids * No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of study treatment * No concurrent radiotherapy, chemotherapy, or other immunotherapy * No previous investigational agent within 4 weeks prior to the start of study treatment