Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
Recruitment status was Active, not recruiting
RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy.
Biological: IL-2 plasmid DNA/lipid complex
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study Evaluating the Safety and Efficacy of Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation Therapy (Summary Last Updated: 02/2001)|
|Study Start Date:||November 2000|
OBJECTIVES: I. Determine the toxicity and tolerability of leuvectin in patients with locally recurrent organ-confined prostate cancer after radiotherapy. II. Determine 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 an open-label, multicenter study. Patients receive leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14. Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|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|