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114 Schroter and Minev
Table 1 Investigational Peptide-Based Vaccines (Continued )
Development
stage Biological/clinical activity Reference
Antigen Tumor type Strategy
76
Phase I Thirty-four out of 40 patients developed a positive
skin test response to only the gp100 peptide and not
the tyrosinase peptide. Thirty-three out of 38 patients
had an immune response by ELISA, and 37 out
of 42 patients had an immune response by tetramer
assay
Phase I No significant peptide-specific T-cell responses were
detected
Phase I CD4þ T cell recruitment and a significant decrease in
circulating regulatory T cells and TGF-beta levels
gp100 and tyrosinase Melanoma Combinatorial
(IL-12)
HER-2/neu Prostate cancer Combinatorial
83
(flt3 ligand)
HER-2/neu Breast cancer Combinatorial
84, 85
(GM-CSF)
hTRT Breast and Monotherapy Phase I hTRT-specific T lymphocytes were induced in 4 of 82
prostate cancer
7 patients; no significant toxicity
hTRT non-small cell Combinatorial Phase I/II Peptides were found safe and immunogenic in all 44
lung cancer (GM-CSF)
26 patients
MAGE-1 Melanoma Monotherapy Phase I All vaccinated patients generated peptide-specific 51
CTL. No therapeutic response was observed
MAGE-A1, MAGE- Melanoma Combinatorial Phase I Peptide-specific T cells were detected in peripheral 78
A10, and gp100
(GM-CSF)
blood and in the sentinel immunized node
MAGE-3 Melanoma Monotherapy Phase I Limited tumor regressions in five out of 17 patients 48
MAGE-3 Melanoma Monotherapy Phase I Significant tumor regressions in 7 out of 25 patients 49
MART-1/Melan-A Melanoma Monotherapy Phase I In vitro detection of successful immunization in 3 of 52
6 patients