Table 1.

Patient characteristics, antigen dose, summary of vaccine-related toxicity, and vaccine-induced immune responses

PatientDisease*StageBefore study status Antigen dose, μgToxicity (grade)Ab §
N14MelanomaIIBNED100L(1), S(1)+
N11MelanomaIIIBNED100L(1), S(1)++
C3Breast cancerINED100L(2)++
C4Breast cancerIIANED100L(1), S(1)+++
C7MelanomaIIINED100L(1), S(1)+++
N13MelanomaIIIANED400L(1), S(1)++++
N4MelanomaIVANED100L(1), S(1)++++++
C5SarcomaIIIM (lung)100L(2), S(2)++++
N2MelanomaIIIBNED100L(1), S(1)+++++
N7MelanomaIIIBNED100L(1), S(1)+++++
N9Ovarian cancerIIICNED400L(1), S(1)++++++
N3MelanomaIIIBNED100L(1), S(1)+++++++
C6SarcomaIIIBNED400L(1), S(1)+++++++
N8MelanomaIICNED100L(1), S(1)+++++++
C2Breast cancerIIANED400L(2), S(2)++++++++
  • *NY-ESO-1 expression in the tumor was not an entrance criterion for this study. However, 10 of 18 patients were tested for NY-ESO-1 expression by immunohistochemistry. Patients N4 and N9 were NY-ESO-1+. Patients C3, C4, C5, C6, N2, N3, N7, and N13 were NY-ESO-1.

  • NED, no evidence of disease; M, metastatic disease.

  • Adverse events with possible, probable, or definite relationship to study drug. L, local toxicity at injection site, included redness, discomfort, itching, induration, erythema, and pain. S, systemic toxicity, included fever, chills, fatigue, cold-like symptoms, sweats, muscle aches, and joint pain.

  • §Ab (week 12 reciprocal serum titer): −, ≤100; +, >100 to 20,000; ++, >20,000 to 40,000; +++, >40,000.

  • CD4 and CD8 (percentage of IFN-γ+ cells after in vitro stimulation): −, ≤0.3%; +, >0.3% to 1%; ++, >1% to 10%; +++, >10%.