Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer

Date de début de l'étude : 1 juin 1999

DISEASE CHARACTERISTICS: Histologically confirmed stage II or III organ confined prostate cancer Resectable disease (candidate for retropubic prostatectomy) Gleason score at least 6 Prostate specific antigen value (PSA) at least 5 ng/mL No significant central nervous system (CNS) disease PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy Not specified Hematopoietic White blood cell count (WBC) greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 9.0 g/dL Hepatic Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal Prothrombin time (PT)/partial thromboplastin time (PTT) normal Albumin greater than 3.0 g/dL Hepatitis B surface antigen negative Renal Creatinine normal Cardiovascular No uncontrolled hypertension No significant cardiovascular disease No history of ventricular dysfunction or arrhythmia No congestive heart failure No symptoms of coronary artery disease No prior myocardial infarction Other No active autoimmune disease No active infection requiring parenteral antibiotics HIV negative No significant psychiatric disorder that would preclude compliance No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer No diabetes mellitus Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for prostate cancer At least 5 years since other prior chemotherapy Endocrine therapy No prior glucocorticoids for prostate cancer At least 5 years since other prior glucocorticoids Radiotherapy No prior radiotherapy for prostate cancer At least 5 years since other prior radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior intrathoracic or intrabdominal surgery At least 2 weeks since other major surgery Other At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents No other neoadjuvant or concurrent anticancer drugs No concurrent immunosuppressive drugs No other concurrent experimental therapy No concurrent parenteral antibiotics