leuvectin followed by surgery in treating patients with stage ii or stage iii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. using leuvectin to deliver this gene may be an effective treatment for prostate cancer. purpose: phase ii trial to study the effectiveness of leuvectin followed by surgery in treating patients who have stage ii or stage iii prostate cancer.

objectives: * assess the toxicity and tolerability of neoadjuvant leuvectin in patients with stage ii or iii prostate cancer. * evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population. outline: this is a multicenter study. patients receive leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7. between days 8 and 14, patients undergo retropubic prostatectomy. all patients are followed at 2 months. patients with a psa no greater than 0.2 ng/ml are followed at 4 months and 6 months, every 3 months for 12 months, and then every 6 months for 3.5 years in the absence of disease progression or biochemical failure. actual accrual: 13 patients were accrued for this study.

Eligibility criteria:
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

Keywords: stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer