Eligibility Prostate Cancer NCT00005072

patient characteristics: age: 18 and over. performance status: karnofsky 80-100% or eastern cooperative oncology group (ecog) 0 or 1. life expectancy: not specified. hematopoietic: white blood cell count (wbc) greater than 3,000/mm3. platelet count greater than 100,000/mm3. hemoglobin greater than 9.0 g/dl. hepatic: bilirubin normal. serum glutamic oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) less than 3 times upper limit of normal. albumin greater than 3 g/dl. prothrombin time (pt) and partial thromboplastin time (ptt) normal. hepatitis b surface antigen negative. renal: creatinine normal. cardiovascular: no uncontrolled hypertension. no significant cardiovascular disease, e.g.: history of ventricular dysfunction; congestive heart failure; symptoms of coronary artery disease; history of any ventricular arrhythmia; prior myocardial infarction. other: hiv negative. fertile patients must use effective double-barrier contraception during and for 3 months after study participation. no active autoimmune disease. no active infection requiring iv antibiotics. no uncontrolled diabetes mellitus. no significant psychiatric disorder that would preclude study. no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer.

prior concurrent therapy: biologic therapy: no prior leuvectin. chemotherapy: at least 3 weeks since prior chemotherapy (6 weeks for mitomycin or hydroxyurea). endocrine therapy: no prior hormonal therapy for prostate cancer. radiotherapy: see disease characteristics. at least 3 weeks since prior radiotherapy. surgery: at least 1 month since prior intrathoracic or intra-abdominal surgery. at least 2 weeks since other prior major surgery. other: at least 10 days since prior anticoagulants or non-steroidal anti-inflammatory agents. no neoadjuvant or other concurrent anticancer drug therapy. no concurrent immunosuppressive drugs. no other concurrent experimental therapy.