Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
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.
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