{"classes":[{"categories":[{"measurements":[{"comment":"This outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.","groupId":"OG000","value":"NA"},{"comment":"This outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.","groupId":"OG001","value":"NA"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes.","groups":[{"description":"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation.\n\nAldesleukin: Given SC\n\nAutologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG000","title":"Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)"},{"description":"Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days.\n\nAldesleukin: Given SC\n\nAutologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG001","title":"Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)"},{"description":"Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion.\n\nAldesleukin: Given SC\n\nAutologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgical resection","id":"OG002","title":"Arm II (T Lymphocytes, IL-2, Surgery)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"No patients were treated in Arm II","reportingStatus":"POSTED","timeFrame":"Up to 100 days after the last T cell infusion","title":"Persistence of Transduced T Cells","type":"PRIMARY","unitOfMeasure":"Participants"}