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)
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.
Primary Purpose: Treatment
Arie Belldegrun, MD, FACS
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|