Vaccine Therapy in Treating Patients With Stage IV Melanoma
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.
Biological: D1/3-MAGE-3-His fusion protein
Biological: SB-AS02B adjuvant
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma|
|Study Start Date:||September 2002|
|Study Completion Date:||March 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042783
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Mississippi|
|Veterans Affairs Medical Center - Biloxi|
|Biloxi, Mississippi, United States, 39531-2410|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, Washington|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98195-6527|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|