Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
OBJECTIVES:
Primary
- 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.
Secondary
- 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
mesothelioma).
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
response.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and immunogenicity
2 years
Yes
Lee M. Krug, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
06-085
NCT00398138
October 2006
June 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |