Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States