NCT00003646

Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Vical · Industry
• Sex: —
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

Detailed description

OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent. II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Conditions

• Stage IV Melanoma
• Stage III Melanoma
• Recurrent Melanoma

Interventions

Type	Name	Description
DRUG	allovectin-7

Timeline

• Start date: 1998-08-01
• Primary completion: 2002-03-01
• Completion: 2002-05-01
• First posted: 2004-05-03
• Last updated: 2011-07-07

Locations

3 sites across 1 country: United States