Lung Cancer Clinical Trial
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
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.
Full 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.
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
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There is 1 Location for this study
New York New York, 10065, United States
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