Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
- Determine objective clinical response in patients with progressive, unresectable
metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination
comprising gp100:209-217 (210M) antigen, MART-1:27-35 antigen, and Montanide ISA-51.
- Determine changes in levels of CD4+, CD25+ regulatory T cells in peripheral blood
before and after treatment in patients treated with this regimen.
- Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination
in these patients.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3. Patients
then receive peptide vaccinations comprising gp100:209-217 (210M) antigen emulsified in
Montanide ISA-51 subcutaneously (SC), and MART-1:27-35 vaccine emulsified in Montanide
ISA-51 SC on days 4, 5, 6, and 24-27 (course 1). After week 8, patients achieving tumor
response may receive 1 additional course in the absence of disease progression or
After completion of study treatment, patients are followed periodically in the absence of
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective clinical response rate
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Surgery Branch||Bethesda, Maryland 20892-1201|