RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood
flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating
patients who have metastatic kidney cancer.
- Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell
- Determine the time to disease progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the effect of this drug on biological surrogates of antitumor activity (basic
fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum
levels) in these patients.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after
initiation of study therapy, and then at completion of study therapy.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.
- 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 #
- Bidimensionally measurable disease
- No brain metastases unless completely resected and without evidence of recurrence for
at least six months
- 18 and over
- Karnofsky 70-100%
- Not specified
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic
- Hepatitis B surface antigen negative
- Hepatitis C negative
- Creatinine no greater than 2 mg/dL
- 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
- No severe asthma requiring chronic systemic steroids
- 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
PRIOR CONCURRENT 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
- No concurrent cytotoxic agents
- 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
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior major surgery
- Concurrent nephrectomy allowed
- At least 14 days since prior anti-infectious therapy
- No other concurrent investigational drugs