Stage IV Melanoma Clinical Trial
Official title:
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make
the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or
without immunotherapy in treating patients who have stage III or stage IV melanoma.
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.
;
Primary Purpose: Treatment
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