Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Vical
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone. II. Determine the benefits, risks, and side effects of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms. Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10. Patients with stable or responding disease may receive additional courses every 28 days. Patients are followed every 4 months. PROJECTED ACCRUAL: A total of 280 patients (140 in each arm) will be accrued for this study.
Age
18–any
Sex
Any
Healthy volunteers
Not accepted
