Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)
OBJECTIVES:
- Determine whether patients with refractory metastatic melanoma undergo partial or
complete response to peptides specific to their HLA-antigen, either alone or when
combined with 1 of 3 adjuvants.
- Evaluate the immunologic response to the peptide alone or when combined with 1 of 3
adjuvants in these patients.
OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).
Patients are assigned to 1 of 4 vaccine groups:
- Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
- Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
- Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
- Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide
vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously
into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3
possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF)
SQ) depending on the time of entry into study and response to treatment.
At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual
on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant
therapy is taken off study. If a second patient develops unacceptable toxicity, that
schedule of peptide administration is discontinued.
Patients exhibiting stable, minor, mixed, or partial response may receive up to 12
additional courses.
Patients are followed for 4-6 weeks.
PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.
Interventional
Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
Study Chair
NCI - Surgery Branch
United States: Federal Government
CDR0000065915
NCT00019383
January 1998
June 2003
Name | Location |
---|---|
Surgery Branch | Bethesda, Maryland 20892 |