Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
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.
Checked against the public recordLast updated Mar 2, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Biological: WT-1 analog peptide vaccine; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Genetic: polymerase chain reaction; Other: flow cytometry; Other: immunoenzyme technique
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Sloan Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 2, 2016. Always confirm current availability with the study team.