Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
- Conditions
- Stage IV MelanomaStage III MelanomaRecurrent Melanoma
- Registration Number
- NCT00003646
- Lead Sponsor
- Vical
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Physician Reliance Network, Inc.
🇺🇸Dallas, Texas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States