Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV 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.
Stage IV Melanoma
Stage III Melanoma
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma|
|Study Start Date:||July 1998|
|Study Completion Date:||September 2002|
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.
A total of 280 patients (140 in each arm) will be accrued for this study.
Show 44 Study Locations
|Study Chair:||Cherie Smith||Vical|