Development in prostate cancer indication halted

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