Study of MAGE-3/Melan-A/gp 100/NA17 and rhIL-12 With/Out Low Dose IL-2 in Metastatic Melanoma
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma
antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4
antigens simultaneously. Immunization with 4 melanoma antigen peptides will increase the
response rate from 10% to 30%. Administration of low-dose IL-2 following each vaccine will
result in a greater than 3-fold increase in specific T cells compared to no IL-2.
Secondary hypotheses: Immunization will clear the blood of detectable circulating melanoma
cells. Tumors that grow despite induction of melanoma antigen-specific T cells may lack
expression of antigens, class I MHC, or the TAP peptide transporter, or may fail to show
increased expression of mRNA for IFN-y or perforin. Tumors that resist vaccination may
express a different array of genes than those that are susceptible to vaccination.