peg-interferon alfa-2b in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: 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.

objectives: * determine the efficacy of peg-interferon alfa-2b in patients with metastatic renal cell carcinoma. * 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.

Eligibility 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

Keywords: stage iv renal cell cancer