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

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