Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
Condition: Leukemia; Lung Cancer; Malignant Mesothelioma; Myelodysplastic Syndromes; Primary Peritoneal Cavity Cancer
MeSH terms: Leukemia; Lung Neoplasms; Preleukemia; Mesothelioma; Mesothelioma, Malignant; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system
      in different ways and stop cancer cells from growing. Giving vaccine therapy together with
      GM-CSF may kill more cancer cells.

      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in
      treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung
      cancer, or mesothelioma.
    

Detailed description: 
      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.
    

Intervention name(s): WT-1 analog peptide vaccine; incomplete Freund's adjuvant; sargramostim; polymerase chain reaction; flow cytometry; immunoenzyme technique
Intervention type(s): Biological; Biological; Biological; Genetic; Other; Other
Intervention MeSH terms: Sargramostim; Freund's Adjuvant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; advanced malignant mesothelioma; recurrent malignant mesothelioma; primary peritoneal cavity cancer