Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
This trial is active, not recruiting.
|Treatments||il-2 plasmid dna/lipid complex, conventional surgery|
|Sponsor||Jonsson Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 1999|
|Trial size||30 participants|
|Trial identifier||NCT00004050, CDR0000067244, NCI-G99-1568, UCLA-9901077-03B, VCL-1102-202|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed stage II or III organ confined prostate cancer - Resectable disease (candidate for retropubic prostatectomy) - Gleason score at least 6 - PSA at least 5 ng/mL - No significant CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% - ECOG 0-1 Life expectancy - Not specified Hematopoietic - 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 SGOT/SGPT less than 3 times upper limit of normal - PT/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 intraabdominal 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
|Official title||Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer|
|Description||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. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.|
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