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

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