A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer
- Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim
(GM-CSF) in patients with stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1
or LAGE antigen.
- Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type
hypersensitivity) in patients treated with this regimen.
- Determine tumor responses in patients treated with this regimen.
OUTLINE: Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a
total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) subcutaneously once
daily beginning 2 days before every vaccination and continuing for 5 days. Treatment
continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12 months.
Primary Purpose: Treatment
Kyriakos P. Papadopoulos, MD
Herbert Irving Comprehensive Cancer Center
United States: Food and Drug Administration
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|