Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Recruitment status was Active, not recruiting
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.
Biological: IL-2 plasmid DNA/lipid complex
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer|
|Study Start Date:||June 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004050
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|