{
"info": {
"nct_id": "NCT00053391",
"official_title": "Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III or IV cutaneous malignant melanoma\n* HLA-A1 and/or HLA-A2 expression by serologic HLA typing\n\n * HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells\n* No active CNS metastases by CT scan or MRI\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 4 months\n\nHematopoietic\n\n* WBC greater than 2,500/mm^3\n* Neutrophil count greater than 1,000/mm^3\n* Lymphocyte count greater than 700/mm^3\n* Platelet count greater than 75,000/mm^3\n* Hemoglobin greater than 9 g/dL\n* No bleeding disorders\n\nHepatic\n\n* Bilirubin less than 2.0 mg/dL\n* Hepatitis B surface antigen negative\n* Hepatitis C antibody negative\n\nRenal\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular\n\n* No clinically significant heart disease\n\nPulmonary\n\n* No clinically significant respiratory disease\n\nImmunologic\n\n* No active systemic infection\n* No immunodeficiency disease\n\n * No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1\n* No active autoimmune disease including (but not limited to):\n\n * Lupus erythematosus\n * Autoimmune thyroiditis or uveitis\n * Multiple sclerosis\n * Inflammatory bowel disease\n\nOther\n\n* Stable medical condition\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 1 month after study participation\n* No organic brain syndrome or psychiatric illness that would preclude study compliance\n* No other concurrent active malignancy\n* No other concurrent serious illness that would preclude study treatment\n* No contraindication to leukapheresis\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior immunotherapy\n* No other concurrent immunotherapy\n\nChemotherapy\n\n* More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent corticosteroids\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n* No prior radiotherapy to the spleen\n* Concurrent palliative radiotherapy allowed\n\nSurgery\n\n* Recovered from prior surgery\n* No prior splenectomy\n* No prior organ allograft\n* Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed\n\nOther\n\n* No other concurrent investigational drugs\n* No concurrent participation in another clinical trial"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically confirmed stage III or IV cutaneous malignant melanoma",
"criterions": [
{
"exact_snippets": "Histologically confirmed",
"criterion": "histological confirmation",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "stage III or IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "cutaneous malignant melanoma",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "cutaneous malignant melanoma"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically confirmed",
"criterion": "histological confirmation",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "stage III or IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "cutaneous malignant melanoma",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "cutaneous malignant melanoma"
}
}
]
}
},
{
"identified_line": {
"line": "* HLA-A1 and/or HLA-A2 expression by serologic HLA typing",
"criterions": [
{
"exact_snippets": "HLA-A1",
"criterion": "HLA-A1 expression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HLA-A2",
"criterion": "HLA-A2 expression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "HLA-A1",
"criterion": "HLA-A1 expression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "HLA-A2",
"criterion": "HLA-A2 expression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells",
"criterions": [
{
"exact_snippets": "HLA-A2.1 subtype must be confirmed",
"criterion": "HLA-A2.1 subtype",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells",
"criterion": "method of confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": "polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HLA-A2.1 subtype must be confirmed",
"criterion": "HLA-A2.1 subtype",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells",
"criterion": "method of confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": "polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells"
}
}
]
}
},
{
"identified_line": {
"line": "* No active CNS metastases by CT scan or MRI",
"criterions": [
{
"exact_snippets": "No active CNS metastases by CT scan or MRI",
"criterion": "CNS metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No active CNS metastases by CT scan or MRI",
"criterion": "CNS metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Age",
"criterions": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Over 18",
"criterions": [
{
"exact_snippets": "Over 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Over 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Performance status",
"criterions": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky 60-100%",
"criterions": [
{
"exact_snippets": "Karnofsky 60-100%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky 60-100%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* At least 4 months",
"criterions": [
{
"exact_snippets": "At least 4 months",
"criterion": "time period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 4 months",
"criterion": "time period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* WBC greater than 2,500/mm^3",
"criterions": [
{
"exact_snippets": "WBC greater than 2,500/mm^3",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2500,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "WBC greater than 2,500/mm^3",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2500,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Neutrophil count greater than 1,000/mm^3",
"criterions": [
{
"exact_snippets": "Neutrophil count greater than 1,000/mm^3",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Neutrophil count greater than 1,000/mm^3",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Lymphocyte count greater than 700/mm^3",
"criterions": [
{
"exact_snippets": "Lymphocyte count greater than 700/mm^3",
"criterion": "lymphocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 700,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lymphocyte count greater than 700/mm^3",
"criterion": "lymphocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 700,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count greater than 75,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count greater than 75,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 75000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count greater than 75,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 75000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin greater than 9 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin greater than 9 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 9,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin greater than 9 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 9,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin less than 2.0 mg/dL",
"criterions": [
{
"exact_snippets": "Bilirubin less than 2.0 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin less than 2.0 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hepatitis B surface antigen negative",
"criterions": [
{
"exact_snippets": "Hepatitis B surface antigen negative",
"criterion": "Hepatitis B surface antigen",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hepatitis B surface antigen negative",
"criterion": "Hepatitis B surface antigen",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Renal",
"criterions": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine less than 2.5 mg/dL",
"criterions": [
{
"exact_snippets": "Creatinine less than 2.5 mg/dL",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine less than 2.5 mg/dL",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "Cardiovascular",
"criterions": [
{
"exact_snippets": "Cardiovascular",
"criterion": "cardiovascular condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cardiovascular",
"criterion": "cardiovascular condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No clinically significant heart disease",
"criterions": [
{
"exact_snippets": "clinically significant heart disease",
"criterion": "heart disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "not clinically significant"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "clinically significant heart disease",
"criterion": "heart disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "not clinically significant"
}
}
]
}
},
{
"identified_line": {
"line": "Pulmonary",
"criterions": [
{
"exact_snippets": "Pulmonary",
"criterion": "pulmonary",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pulmonary",
"criterion": "pulmonary",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No clinically significant respiratory disease",
"criterions": [
{
"exact_snippets": "clinically significant respiratory disease",
"criterion": "respiratory disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "not clinically significant"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "clinically significant respiratory disease",
"criterion": "respiratory disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "not clinically significant"
}
}
]
}
},
{
"identified_line": {
"line": "Immunologic",
"criterions": [
{
"exact_snippets": "Immunologic",
"criterion": "immunologic",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Immunologic",
"criterion": "immunologic",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1",
"criterions": [
{
"exact_snippets": "No evidence of HIV-1",
"criterion": "HIV-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No evidence of ... HIV-2",
"criterion": "HIV-2",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No evidence of ... human T-cell lymphotropic virus-1",
"criterion": "human T-cell lymphotropic virus-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No evidence of HIV-1",
"criterion": "HIV-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No evidence of ... HIV-2",
"criterion": "HIV-2",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No evidence of ... human T-cell lymphotropic virus-1",
"criterion": "human T-cell lymphotropic virus-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No active autoimmune disease including (but not limited to):",
"criterions": [
{
"exact_snippets": "No active autoimmune disease",
"criterion": "active autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No active autoimmune disease",
"criterion": "active autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "* Fertile patients must use effective contraception during and for at least 1 month after study participation",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirement": {
"requirement_type": "status",
"expected_value": "fertile"
}
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "during and for at least 1 month after study participation",
"criterion": "contraception duration",
"requirement": {
"requirement_type": "duration",
"expected_value": "during and for at least 1 month after study participation"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirement": {
"requirement_type": "status",
"expected_value": "fertile"
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "during and for at least 1 month after study participation",
"criterion": "contraception duration",
"requirement": {
"requirement_type": "duration",
"expected_value": "during and for at least 1 month after study participation"
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* No organic brain syndrome or psychiatric illness that would preclude study compliance",
"criterions": [
{
"exact_snippets": "No organic brain syndrome",
"criterion": "organic brain syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No ... psychiatric illness that would preclude study compliance",
"criterion": "psychiatric illness",
"requirement": {
"requirement_type": "impact on study compliance",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No organic brain syndrome",
"criterion": "organic brain syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No ... psychiatric illness that would preclude study compliance",
"criterion": "psychiatric illness",
"requirement": {
"requirement_type": "impact on study compliance",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No other concurrent active malignancy",
"criterions": [
{
"exact_snippets": "No other concurrent active malignancy",
"criterion": "concurrent active malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No other concurrent active malignancy",
"criterion": "concurrent active malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* No other concurrent serious illness that would preclude study treatment",
"criterions": [
{
"exact_snippets": "No other concurrent serious illness",
"criterion": "concurrent serious illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No other concurrent serious illness",
"criterion": "concurrent serious illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Biologic therapy",
"criterions": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* More than 4 weeks since prior immunotherapy",
"criterions": [
{
"exact_snippets": "More than 4 weeks since prior immunotherapy",
"criterion": "time since prior immunotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 4 weeks since prior immunotherapy",
"criterion": "time since prior immunotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No other concurrent immunotherapy",
"criterions": [
{
"exact_snippets": "No other concurrent immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No other concurrent immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "Chemotherapy",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)",
"criterions": [
{
"exact_snippets": "More than 4 weeks since prior systemic chemotherapy",
"criterion": "time since prior systemic chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "6 weeks for nitrosoureas",
"criterion": "time since prior nitrosoureas chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "More than 4 weeks since prior systemic chemotherapy",
"criterion": "time since prior systemic chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
},
{
"not_criteria": {
"exact_snippets": "6 weeks for nitrosoureas",
"criterion": "time since prior nitrosoureas chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "weeks"
}
}
}
}
]
},
{
"exact_snippets": "6 weeks for nitrosoureas",
"criterion": "time since prior nitrosoureas chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No concurrent chemotherapy",
"criterions": [
{
"exact_snippets": "No concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Radiotherapy",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* More than 4 weeks since prior radiotherapy",
"criterions": [
{
"exact_snippets": "More than 4 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 4 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Concurrent palliative radiotherapy allowed",
"criterions": [
{
"exact_snippets": "Concurrent palliative radiotherapy allowed",
"criterion": "palliative radiotherapy",
"requirement": {
"requirement_type": "concurrency",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Concurrent palliative radiotherapy allowed",
"criterion": "palliative radiotherapy",
"requirement": {
"requirement_type": "concurrency",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Recovered from prior surgery",
"criterions": [
{
"exact_snippets": "Recovered from prior surgery",
"criterion": "recovery from prior surgery",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recovered from prior surgery",
"criterion": "recovery from prior surgery",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
}
]
}
},
{
"identified_line": {
"line": "* No prior splenectomy",
"criterions": [
{
"exact_snippets": "No prior splenectomy",
"criterion": "splenectomy",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No prior splenectomy",
"criterion": "splenectomy",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No prior organ allograft",
"criterions": [
{
"exact_snippets": "No prior organ allograft",
"criterion": "organ allograft",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior organ allograft",
"criterion": "organ allograft",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed",
"criterions": [
{
"exact_snippets": "Concurrent surgery on selected metastases ... allowed",
"criterion": "concurrent surgery on selected metastases",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "pain",
"criterion": "pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "local complications such as compression",
"criterion": "local complications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"or_criteria": [
{
"exact_snippets": "pain",
"criterion": "pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "local complications such as compression",
"criterion": "local complications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "Concurrent surgery on selected metastases ... allowed",
"criterion": "concurrent surgery on selected metastases",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* No other concurrent investigational drugs",
"criterions": [
{
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* No concurrent participation in another clinical trial",
"criterions": [
{
"exact_snippets": "No concurrent participation in another clinical trial",
"criterion": "concurrent participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No concurrent participation in another clinical trial",
"criterion": "concurrent participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Other",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Other",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* No bleeding disorders",
"criterions": [
{
"exact_snippets": "No bleeding disorders",
"criterion": "bleeding disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No bleeding disorders",
"criterion": "bleeding disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Hepatitis C antibody negative",
"criterions": [
{
"exact_snippets": "Hepatitis C antibody negative",
"criterion": "Hepatitis C antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Hepatitis C antibody negative",
"criterion": "Hepatitis C antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No active systemic infection",
"criterions": [
{
"exact_snippets": "No active systemic infection",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No active systemic infection",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No immunodeficiency disease",
"criterions": [
{
"exact_snippets": "No immunodeficiency disease",
"criterion": "immunodeficiency disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No immunodeficiency disease",
"criterion": "immunodeficiency disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Lupus erythematosus",
"criterions": [
{
"exact_snippets": "Lupus erythematosus",
"criterion": "Lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Autoimmune thyroiditis or uveitis",
"criterions": [
{
"exact_snippets": "Autoimmune thyroiditis",
"criterion": "autoimmune thyroiditis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uveitis",
"criterion": "uveitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Multiple sclerosis",
"criterions": [
{
"exact_snippets": "Multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Inflammatory bowel disease",
"criterions": [
{
"exact_snippets": "Inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Stable medical condition",
"criterions": [
{
"exact_snippets": "Stable medical condition",
"criterion": "medical condition",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* No contraindication to leukapheresis",
"criterions": [
{
"exact_snippets": "No contraindication to leukapheresis",
"criterion": "leukapheresis contraindication",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No contraindication to leukapheresis",
"criterion": "leukapheresis contraindication",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No concurrent corticosteroids",
"criterions": [
{
"exact_snippets": "No concurrent corticosteroids",
"criterion": "corticosteroids",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent corticosteroids",
"criterion": "corticosteroids",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No prior radiotherapy to the spleen",
"criterions": [
{
"exact_snippets": "No prior radiotherapy to the spleen",
"criterion": "radiotherapy to the spleen",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior radiotherapy to the spleen",
"criterion": "radiotherapy to the spleen",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
}
}
]
}