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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Leuvectin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leuvectin<br>2 intratumoral injections of 1000 ug of Leuvectin | Biological: Leuvectin<br>* Leuvectin injected intratumorally followed by prostatectomy<br>* Other names: Interleukin-2 (IL-2) plasmid DNA/lipid complex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease recurrence | Measure timing and rate of disease recurrence | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Leuvectin |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer