A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.
This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or
LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5mL of Montanide ISA-51
and 1mg of CpG7909 given every three weeks for four doses by subcutaneous injection. There
will be a three-week follow-up period after the fourth injection making the cycle 13 weeks
long. In the absence of toxicity and progressive disease, a second cycle will be offered to
patients who have received four vaccinations.
The primary objective is to evaluate the immune response (antibodies, CD8+ T cells, and DTH)
and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide in
patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document
tumor responses in patients with evaluable or measurable disease.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
NY-ESO-1 specific humoral immunity
Nasser K Altorki, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration