Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma

Date de début de l'étude : 1 janvier 1999

DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Bidimensionally measurable disease No active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 No coagulation disorders Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal No clinically significant hepatic disease, including autoimmune hepatitis Renal: Creatinine less than 2 mg/dL OR Creatinine clearance greater than 50 mL/min No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease No thrombophlebitis Pulmonary: No severe debilitating pulmonary disease No pulmonary embolism Other: No history of diabetes mellitus prone to ketoacidosis No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study No thyroid abnormalities that hinder maintaining thyroid function at the normal range No severe infection No severe malnutrition No clinically significant retinal abnormalities No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biological response modifier therapy or immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery Other: No prior retinoid therapy