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
- 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
- Determine the qualitative and quantitative toxic effects of this regimen in these
- 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
Masking: Open Label, Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Veterans Affairs Medical Center - Biloxi||Biloxi, Mississippi 39531-2410|
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|University of Washington School of Medicine||Seattle, Washington 98195|