Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
- 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.
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