Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
- Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in
patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung
cancer, or mesothelioma.
- Determine the antitumor effects of this vaccine in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease type (acute
myeloid leukemia [AML] or myelodysplastic syndromes [MDS] vs non-small cell lung cancer or
Patients receive vaccine comprising Wilms-tumor 1 (WT-1) analog peptide emulsified in
Montanide ISA-51 subcutaneously (SC) once in weeks 0, 4, 6, 8, 10, and 12 and sargramostim
(GM-CSF) SC twice in weeks 0, 4, 6, 8, 10, and 12 (on the day of and 2 days prior to each
vaccination). Patients who have an immunologic response and have no disease progression may
receive up to 6 more vaccinations approximately 1 month apart.
Blood samples are collected at baseline, week 8, and week 14. Samples are examined by
polymerase chain reaction (PCR) to measure levels of WT-1 and by T-cell proliferative
response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT to measure immune
Bone marrow samples are collected from patients with AML or MDS at baseline and week 14.
Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry
to measure residual disease.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and immunogenicity
Lee M. Krug, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|