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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer|
- Disease recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]Measure timing and rate of disease recurrence
- Safety of Leuvectin [ Designated as safety issue: Yes ]
|Study Start Date:||June 1999|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
2 intratumoral injections of 1000 ug of Leuvectin
Leuvectin injected intratumorally followed by prostatectomy
Other Name: Interleukin-2 (IL-2) plasmid DNA/lipid complex
- 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.
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|