Study: NCT00819806

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine only
Description: PF-3512676, Montanide ISA 720 VG and MHC class I peptides from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. The remaining 1.5 ml will be used for sterility testing. Each injection will be done in the vicinity of the nodal drainage of one extremity.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine + cyclophosphamide
Description: PF-3512676, Montanide ISA 720 VG and three MHC class I-restricted epitopes from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) and cyclophosphamide. The vaccine preparation is identical to arm A. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine only
Description: PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102) and three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine + cyclophosphamide
Description: PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102), three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) and cyclophosphamide. The vaccine preparation is identical to arm C. Low-dose cyclophosphamide (300mg/m2) IV will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine only
Description: PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injection (i.e. 3 mg of PF-3512676 or 300 μl of PF-3512676 at 10mg/ml, 300 μg or 900 μl of protein NY-ESO-1 at 0.35 mg/ml + Montanide ISA 720 VG). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml SC injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine + cyclophosphamide
Description: PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injections and cyclophosphamide. The vaccine preparation is identical to arm E. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.