An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma
- Determine the clinical response in patients with stage IV melanoma when treated with
anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with
gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
- Determine a safety and adverse event profile of this regimen in these patients.
- Determine improved immunologic response in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV
over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified
in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|