NCT00004050

Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Vical · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Leuvectin	Leuvectin injected intratumorally followed by prostatectomy

Timeline

• Start date: 1999-06-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2003-10-29
• Last updated: 2014-07-29

Locations

2 sites across 1 country: United States