PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed renal cell carcinoma
• •* Metastatic disease
• •* No prior therapy for advanced disease
• •Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076
• •Bidimensionally measurable disease
• •No brain metastases unless completely resected and without evidence of recurrence for at least six months
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC at least 3,000/mm3
• •Platelet count at least 100,000/mm3
• •Hepatic
• •Bilirubin no greater than 1.5 mg/dL
• •SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases)
• •Hepatitis B surface antigen negative
• •Hepatitis C negative
• •Renal
• •Creatinine no greater than 2 mg/dL
• •Cardiovascular
• •No severe cardiac disease
• •No New York Heart Association class III or IV cardiac disease
• •No myocardial infarction within the past 12 months
• •No ventricular tachyarrhythmias requiring ongoing treatment
• •No unstable angina
• •Pulmonary
• •No severe asthma requiring chronic systemic steroids
• •Other
• •HIV negative
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer
• •* Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible
• •No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization
• •No prior or active autoimmune disease
• •Medically controlled diabetes or thyroid dysfunction allowed
• •No clinically significant acute viral or bacterial infection that requires specific therapy
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior interleukin-2
• •No prior interferon alfa
• •No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise
• •No concurrent tumor vaccines
• •No concurrent monoclonal antibodies
• •No concurrent bone marrow/stem cell transplantation
• •Chemotherapy
• •No concurrent cytotoxic agents
• •Endocrine therapy
• •No concurrent high-dose systemic steroids
• •Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed
• •No concurrent hormonal therapy (including megestrol)
• •Concurrent hormone replacement therapy or oral contraceptives allowed
• •Radiotherapy
• •At least 4 weeks since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •See Disease Characteristics
• •At least 4 weeks since prior major surgery
• •Concurrent nephrectomy allowed
• •Other
• •At least 14 days since prior anti-infectious therapy
• •No other concurrent investigational drugs