RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
OBJECTIVES: * Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant. * Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen. * Determine the 6-month progression-free survival rate of patients treated with this regimen. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine immune responses in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
University of Washington School of Medicine
Seattle, Washington, United States