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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Jennifer Fernandez
Study Chair
Vical
United States: Food and Drug Administration
CDR0000066735
NCT00003646
August 1998
May 2002
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Physician Reliance Network, Inc. | Dallas, Texas 75246 |