An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma
- Determine the safety and adverse event profile of anti-cytotoxic
T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376,
gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients
with resected stage III or IV melanoma.
- Determine if this regimen causes antigen-specific T-cell activation in these patients.
- Determine the clearance profile of this regimen in these patients.
- Assess the development of host immune response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4
monoclonal antibody (MDX-CTLA4).
Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in
Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4,
5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum
tolerated dose is determined.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|