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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Biological: Leuvectin

• Registration Number: NCT00004050
• Lead Sponsor: Vical

Brief 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.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 1999-12-10
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted QC: 2003-10-28
• Study First Posted: 2003-10-29
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leuvectin	Leuvectin	2 intratumoral injections of 1000 ug of Leuvectin

Primary Outcome Measures

Name	Time	Method
Disease recurrence	2 years	Measure timing and rate of disease recurrence

Secondary Outcome Measures

Name	Time	Method
Safety of Leuvectin

Trial Locations

Locations (2)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States