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