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
Intervention: WT-1 analog peptide vaccine; incomplete Freund's adjuvant; sargramostim; polymerase chain reaction; flow cytometry; immunoenzyme technique
Intervention MeSH terms: Sargramostim; Freund's Adjuvant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytologically or histologically confirmed diagnosis of 1 of the following:

               -  Acute myeloid leukemia, meeting the following criteria:

                    -  Documented Wilms tumor-1 (WT-1)-positive disease demonstrated by WT-1
                       protein on a pretreatment bone marrow biopsy OR detectable disease with
                       real-time quantitative reverse transcriptase-polymerase chain reaction
                       (RQ-PCR)

                    -  Completed induction chemotherapy, achieved clinical remission, and completed
                       postremission therapy OR achieved clinical remission and have no plans for
                       further postremission chemotherapy (≥ 65 years of age)

               -  Myelodysplastic syndromes, meeting the following criteria:

                    -  Documented WT-1-positive disease demonstrated by WT-1 protein on a
                       pretreatment bone marrow biopsy OR detectable disease by RQ-PCR

                    -  International Prognostic Scoring System (IPSS) score of ≥ Int-2

                    -  Not a candidate for cytotoxic chemotherapy

               -  Non-small cell lung cancer, meeting the following criteria:

                    -  Positive tumor staining for WT-1 in > 10% of cells

                    -  Stage III or IV disease

                    -  Completed chemotherapy, surgery, and/or radiotherapy

               -  Mesothelioma, meeting the following criteria:

                    -  Positive tumor staining for WT-1 in > 10% of cells

                    -  Unresectable or relapsed disease

                    -  Chemo-naive or received 1 prior chemotherapy regimen

                    -  Malignant pleural mesothelioma or peritoneal mesothelioma

          -  No leptomeningeal disease

          -  No CNS involvement

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count > 50,000/mm³ (except for myelodysplastic syndromes where parameter is >
             20,000/mm³ and not transfusion dependent)

          -  Bilirubin ≤ 2.0 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatinine ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring systemic antibiotics, antiviral, or antifungal
             treatments

          -  No serious unstable medical illness

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior chemotherapy or radiotherapy

          -  No concurrent systemic corticosteroids