Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer

Phase 1

Terminated

• Conditions: Prostate Cancer
• Interventions: Biological: Leuvectin

• Registration Number: NCT00005072
• Lead Sponsor: Vical

Brief Summary

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.

Detailed Description

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.

ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.

Study Timeline

• Study First Submitted: 2000-04-06
• Study Start: 2000-11
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted QC: 2003-11-03
• Study First Posted: 2003-11-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leuvectin	Leuvectin	Leuvectin

Primary Outcome Measures

Name	Time	Method
Safety of Leuvectin

Trial Locations

Locations (2)

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

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