Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
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
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
A total of 70 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Physician Reliance Network, Inc.||Dallas, Texas 75246|