Primary Outcome Measures:
- Safety and immunogenicity [ Designated as safety issue: Yes ]
- Immune response as measured by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Antileukemic effects [ Designated as safety issue: No ]
- Clinical and molecular response [ Designated as safety issue: No ]
- Antitumor response as measured by CT scan based on RECIST criteria [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC v. 3.0 [ Designated as safety issue: Yes ]
- 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 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.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.