Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
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.
Stage IV Melanoma
Stage III Melanoma
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma|
|Study Start Date:||August 1998|
|Study Completion Date:||May 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
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.
A total of 70 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003646
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Texas|
|Physician Reliance Network, Inc.|
|Dallas, Texas, United States, 75246|
|Study Chair:||Jennifer Fernandez||Vical|