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