• Progressive disease is a new bone lesion on bone scan, progression of nodal or soft tissue, or a 50% increase in prostate specific antigen (PSA) level from the nadir PSA level confirm twice and measured at least two weeks apart. [ Time Frame: Tumor evaluation assessment will be performed prior to vaccine 1 (week 1) and every 12 weeks. ] [ Designated as safety issue: Yes ]
  

Biological: NY-ESO-1 class I and class II peptide vaccine
The treatment cycle is 6 subcutaneous injections administered every other week for 12 weeks of NY-ESO-1/LAGE-1 vaccine (weeks 1, 3, 5, 7, 9, 11 (±3 days)). The vaccinations will be given in the upper arm region, in a volume of 1 milliliter. The dose will be 1000 mcg of peptide (1 mg). Patients will be evaluated for clinical/ immunological responses at weeks 5 and 11.
Biological: LAGE-1 class I and class II peptide vaccine
The treatment cycle is 6 subcutaneous injections administered every other week for 12 weeks of NY-ESO-1/LAGE-1 vaccine (weeks 1, 3, 5, 7, 9, 11 (±3 days)). The vaccinations will be given in the upper arm region, in a volume of 1 milliliter. The dose will be 1000 mcg of peptide (1 mg). Patients will be evaluated for clinical/ immunological responses at weeks 5 and 11.

Nine subjects will participate in this Phase I study that is designed to evaluate the safety and biology of class I and class II NY-ESO-1/LAGE-1 vaccine with an intent to offer a therapeutic advantage. The treatment cycle is 6 subcutaneous injections administered every other week for 12 weeks of NY-ESO-1/LAGE-1 vaccine (weeks 1, 3, 5, 7, 9, 11 (±3 days)). The vaccinations will be given in the upper arm region, in a volume of 1 milliliter. The dose will be 1000 mcg of peptide (1 mg). Patients will be evaluated for clinical/immunological responses at weeks 5 and 11. The vaccine schedule is similar to that of many prior peptide vaccine studies, in which the schedule was based on earlier animal studies but empirically derived in human studies (32-34, 36-39).

The first patients will be enrolled to receive subcutaneous vaccination with either class I or II NY-ESO-1/ LAGE-1 peptide (1000 mcg). Thus, the trial will test the toxicity of the vaccine with 3 patients in each of 2 vaccine groups, one receiving Class I (group I) and the other Class II peptide (group II). If no significant toxicity is observed after a treatment cycle of 12 weeks, then three patients will receive a combination of both peptides (group III).