NY-ESO-1 Protein Immunization of Post-Cystectomy Patients With Transitional Cell Carcinomas Expressing NY-ESO-1 or LAGE-1 Antigen
- Determine the safety and tolerability of NY-ESO-1 peptide vaccine, BCG, and
sargramostim (GM-CSF) in post-cystectomy patients with transitional cell carcinoma of
the bladder expressing NY-ESO-1 or LAGE-1 antigen.
- Determine the immunological profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type
hypersensitivity) induced by this regimen in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive NY-ESO-1 peptide vaccine mixed with BCG intradermally (ID) once weekly on
weeks 1 and 2. Patients then receive NY-ESO-1 peptide mixed with sargramostim (GM-CSF) ID
once weekly on day 2 of weeks 3-6. Patients also receive GM-CSF subcutaneously alone on days
1, 3, 4, and 5 of weeks 3-6. Treatment continues in the absence of disease progression or
Patients are followed at 2 and 6 weeks.
PROJECTED ACCRUAL: A total of 24-28 patients (8 HLA-A2 positive with prior intravesical BCG,
8 HLA-A2 positive without prior intravesical BCG, 4-6 HLA-A2 negative with prior
intravesical BCG, and 4-6 HLA-A2 negative without prior intravesical BCG) will be accrued
for this study within 15 months.
Masking: Open Label, Primary Purpose: Treatment
Dean F. Bajorin, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|