Melanoma (Skin) Clinical Trial
Official title:
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal
cells. Vaccines made from peptides may help the body build an effective immune response to
kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with
vaccine therapy works in treating patients with metastatic melanoma that cannot be removed
by surgery.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
unacceptable toxicity.
After completion of study treatment, patients are followed periodically in the absence of
disease progression.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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