PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center