Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven metastatic renal cell carcinoma
• •* Clear cell
• •* Papillary
• •* Sarcomatoid
• •* Mixed
• •Measurable or evaluable disease
• •Evidence of disease following surgical resection of metastases
• •No CNS disease
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Hemoglobin at least 10 g/dL
• •WBC at least 4,000/mm3
• •Platelet count at least 100,000/mm3
• •Hepatic:
• •Not specified
• •Renal:
• •Creatinine no greater than 1.8 mg/dL
• •Cardiovascular:
• •No New York Heart Association class III or IV heart disease
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception (barrier plus 1 other method)
• •Thyroid-stimulating hormone normal
• •No known hypersensitivity or allergy to components of recombinant human interleukin-2
• •No known autoimmune disease (e.g., Crohn's disease)
• •No other concurrent medical condition that would preclude study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior recombinant human interleukin-2
• •No concurrent interferon alfa
• •Chemotherapy:
• •No concurrent cytoxic chemotherapy
• •Endocrine therapy:
• •No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
• •No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
• •No concurrent systemic corticosteroids
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy
• •No prior radiotherapy to index lesion
• •No concurrent radiotherapy
• •Surgery:
• •See Disease Characteristics
• •Prior surgery for renal cell carcinoma allowed
• •Other:
• •No prior systemic therapy for renal cell carcinoma
• •At least 4 weeks since prior investigational drugs
• •No other concurrent investigational drugs or participation in another clinical study
• •No concurrent iodinated radiocontrast dye
• •No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)