Lung Cancer Clinical Trial
Official title:
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Innovive Pharmaceuticals, National Cancer Institute (NCI) |
United States,
Maslak PG, Dao T, Krug LM, Chanel S, Korontsvit T, Zakhaleva V, Zhang R, Wolchok JD, Yuan J, Pinilla-Ibarz J, Berman E, Weiss M, Jurcic J, Frattini MG, Scheinberg DA. Vaccination with synthetic analog peptides derived from WT1 oncoprotein induces T-cell r — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0). | 2 years | Yes |
Primary | Immune Response | Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well. | 2 years | No |
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