Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
