{
"info": {
"nct_id": "NCT01291420",
"official_title": "Therapeutic Efficacy of Wilms' Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Solid Tumors: a Phase I/feasibility Study",
"inclusion_criteria": "1. Tumor type:\n\n Metastatic or Locally Advanced Breast Cancer; Malignant Mesothelioma; Glioblastoma Multiforme (Grade IV); Sarcoma's; Colorectal tumors or rare tumors (less than 500 patients a year)\n2. Extent of disease:\n\n * Metastatic Breast Cancer or High Risk Locally Advanced Breast Cancer\n\n * Partial or Complete response after first line chemotherapy for both metastatic or locally advanced breast cancer. Minimal metastatic disease under hormonal treatment\n * High risk Locally Advanced breast cancer defined as (and/or):\n\n * Age < 60 years old\n * ER, PR and Her-2 Neu negative tumors\n * > 4 lymphnodes at initial presentation\n * Mastitis Carcinomatosis\n * Pregnancy associated Breast Cancer\n * Malignant Mesothelioma:\n\n * Partial or Complete response after first line chemotherapy not amendable for surgery\n * Adjuvant after debulking surgery\n * Glioblastoma Multiforme\n\n * In Recurrent Disease after optimal treatment according to Stupp regimen\n * In primary disease after debulking surgery, Temodal/radiotherapy and Temodal chemotherapy for 6 months\n * Sarcoma's\n\n * After adjuvant chemotherapy for uterine sarcoma's\n * After Optimal or Debulking Surgery for liposarcoma's, synovial cell sarcoma's\n * Recurrent sarcoma's with limited disease\n * Colorectal tumors\n\n * K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)\n3. Patient Characteristics\n\n * Prior treatments: Patients must have received at least one prior chemotherapeutic regimen and must be more than 1 month past the last treatment.\n * Age: ≥ 18 years old\n * Performance status: WHO PS grade 0-1 (Appendix B)\n * Objectively assessable parameters of life expectancy: more than 3 months\n * Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV\n * No concomitant use of immunosuppressive drugs, hormonal treatment for breast cancer is allowed in case of stable disease\n * Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal\n * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n * Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)\n2. Subjects who are pregnant\n3. Subjects who have sensitivity to drugs that provide local anesthesia\n4. Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Tumor type:",
"criterions": [
{
"exact_snippets": "Tumor type",
"criterion": "tumor type",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tumor type",
"criterion": "tumor type",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "Metastatic or Locally Advanced Breast Cancer; Malignant Mesothelioma; Glioblastoma Multiforme (Grade IV); Sarcoma's; Colorectal tumors or rare tumors (less than 500 patients a year)",
"criterions": [
{
"exact_snippets": "Metastatic or Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"metastatic",
"locally advanced"
]
}
},
{
"exact_snippets": "Malignant Mesothelioma",
"criterion": "mesothelioma",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "Glioblastoma Multiforme (Grade IV)",
"criterion": "glioblastoma multiforme",
"requirement": {
"requirement_type": "grade",
"expected_value": "IV"
}
},
{
"exact_snippets": "Sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Colorectal tumors",
"criterion": "colorectal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rare tumors (less than 500 patients a year)",
"criterion": "rare tumors",
"requirement": {
"requirement_type": "incidence",
"expected_value": {
"operator": "<",
"value": 500,
"unit": "patients per year"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Metastatic or Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"metastatic",
"locally advanced"
]
}
}
]
},
{
"exact_snippets": "Malignant Mesothelioma",
"criterion": "mesothelioma",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "Glioblastoma Multiforme (Grade IV)",
"criterion": "glioblastoma multiforme",
"requirement": {
"requirement_type": "grade",
"expected_value": "IV"
}
},
{
"exact_snippets": "Sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Colorectal tumors",
"criterion": "colorectal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rare tumors (less than 500 patients a year)",
"criterion": "rare tumors",
"requirement": {
"requirement_type": "incidence",
"expected_value": {
"operator": "<",
"value": 500,
"unit": "patients per year"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Extent of disease:",
"criterions": [
{
"exact_snippets": "Extent of disease",
"criterion": "extent of disease",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Extent of disease",
"criterion": "extent of disease",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Metastatic Breast Cancer or High Risk Locally Advanced Breast Cancer",
"criterions": [
{
"exact_snippets": "Metastatic Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
},
{
"exact_snippets": "High Risk Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "risk",
"expected_value": "high"
}
},
{
"exact_snippets": "High Risk Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Metastatic Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "High Risk Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "risk",
"expected_value": "high"
}
},
{
"exact_snippets": "High Risk Locally Advanced Breast Cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Partial or Complete response after first line chemotherapy for both metastatic or locally advanced breast cancer. Minimal metastatic disease under hormonal treatment",
"criterions": [
{
"exact_snippets": "Partial or Complete response after first line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"Partial",
"Complete"
]
}
},
{
"exact_snippets": "metastatic or locally advanced breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"metastatic",
"locally advanced"
]
}
},
{
"exact_snippets": "Minimal metastatic disease under hormonal treatment",
"criterion": "metastatic disease status under hormonal treatment",
"requirement": {
"requirement_type": "status",
"expected_value": "Minimal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Partial or Complete response after first line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"Partial",
"Complete"
]
}
},
{
"exact_snippets": "metastatic or locally advanced breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"metastatic",
"locally advanced"
]
}
}
]
},
{
"exact_snippets": "Minimal metastatic disease under hormonal treatment",
"criterion": "metastatic disease status under hormonal treatment",
"requirement": {
"requirement_type": "status",
"expected_value": "Minimal"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* High risk Locally Advanced breast cancer defined as (and/or):",
"criterions": [
{
"exact_snippets": "High risk Locally Advanced breast cancer",
"criterion": "Locally Advanced breast cancer",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "High risk Locally Advanced breast cancer",
"criterion": "Locally Advanced breast cancer",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
}
]
}
},
{
"identified_line": {
"line": "* Age < 60 years old",
"criterions": [
{
"exact_snippets": "Age < 60 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age < 60 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* ER, PR and Her-2 Neu negative tumors",
"criterions": [
{
"exact_snippets": "ER ... negative tumors",
"criterion": "ER status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "PR ... negative tumors",
"criterion": "PR status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "Her-2 Neu negative tumors",
"criterion": "Her-2 Neu status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ER ... negative tumors",
"criterion": "ER status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "PR ... negative tumors",
"criterion": "PR status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "Her-2 Neu negative tumors",
"criterion": "Her-2 Neu status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "* > 4 lymphnodes at initial presentation",
"criterions": [
{
"exact_snippets": "> 4 lymphnodes at initial presentation",
"criterion": "lymph nodes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "> 4 lymphnodes at initial presentation",
"criterion": "lymph nodes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Mastitis Carcinomatosis",
"criterions": [
{
"exact_snippets": "Mastitis Carcinomatosis",
"criterion": "Mastitis Carcinomatosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Mastitis Carcinomatosis",
"criterion": "Mastitis Carcinomatosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy associated Breast Cancer",
"criterions": [
{
"exact_snippets": "Pregnancy associated Breast Cancer",
"criterion": "Pregnancy associated Breast Cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pregnancy associated Breast Cancer",
"criterion": "Pregnancy associated Breast Cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Malignant Mesothelioma:",
"criterions": [
{
"exact_snippets": "Malignant Mesothelioma",
"criterion": "Malignant Mesothelioma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Malignant Mesothelioma",
"criterion": "Malignant Mesothelioma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Partial or Complete response after first line chemotherapy not amendable for surgery",
"criterions": [
{
"exact_snippets": "Partial or Complete response after first line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Partial",
"Complete"
]
}
},
{
"exact_snippets": "not amendable for surgery",
"criterion": "surgical amendability",
"requirement": {
"requirement_type": "amendability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Partial or Complete response after first line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Partial",
"Complete"
]
}
},
{
"exact_snippets": "not amendable for surgery",
"criterion": "surgical amendability",
"requirement": {
"requirement_type": "amendability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Adjuvant after debulking surgery",
"criterions": [
{
"exact_snippets": "Adjuvant after debulking surgery",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "after debulking surgery"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adjuvant after debulking surgery",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "after debulking surgery"
}
}
]
}
},
{
"identified_line": {
"line": "* Glioblastoma Multiforme",
"criterions": [
{
"exact_snippets": "Glioblastoma Multiforme",
"criterion": "Glioblastoma Multiforme",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Glioblastoma Multiforme",
"criterion": "Glioblastoma Multiforme",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* In Recurrent Disease after optimal treatment according to Stupp regimen",
"criterions": [
{
"exact_snippets": "Recurrent Disease",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "optimal treatment according to Stupp regimen",
"criterion": "treatment history",
"requirement": {
"requirement_type": "specific treatment",
"expected_value": "Stupp regimen"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recurrent Disease",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "optimal treatment according to Stupp regimen",
"criterion": "treatment history",
"requirement": {
"requirement_type": "specific treatment",
"expected_value": "Stupp regimen"
}
}
]
}
},
{
"identified_line": {
"line": "* Sarcoma's",
"criterions": [
{
"exact_snippets": "Sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* After adjuvant chemotherapy for uterine sarcoma's",
"criterions": [
{
"exact_snippets": "adjuvant chemotherapy",
"criterion": "adjuvant chemotherapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "uterine sarcoma",
"criterion": "uterine sarcoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "adjuvant chemotherapy",
"criterion": "adjuvant chemotherapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "uterine sarcoma",
"criterion": "uterine sarcoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* After Optimal or Debulking Surgery for liposarcoma's, synovial cell sarcoma's",
"criterions": [
{
"exact_snippets": "After Optimal or Debulking Surgery",
"criterion": "surgery type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Optimal",
"Debulking"
]
}
},
{
"exact_snippets": "liposarcoma's",
"criterion": "liposarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "synovial cell sarcoma's",
"criterion": "synovial cell sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "After Optimal or Debulking Surgery",
"criterion": "surgery type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Optimal",
"Debulking"
]
}
},
{
"exact_snippets": "liposarcoma's",
"criterion": "liposarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "After Optimal or Debulking Surgery",
"criterion": "surgery type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Optimal",
"Debulking"
]
}
},
{
"exact_snippets": "synovial cell sarcoma's",
"criterion": "synovial cell sarcoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Recurrent sarcoma's with limited disease",
"criterions": [
{
"exact_snippets": "Recurrent sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "limited disease",
"criterion": "disease extent",
"requirement": {
"requirement_type": "extent",
"expected_value": "limited"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recurrent sarcoma's",
"criterion": "sarcoma",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "limited disease",
"criterion": "disease extent",
"requirement": {
"requirement_type": "extent",
"expected_value": "limited"
}
}
]
}
},
{
"identified_line": {
"line": "* Colorectal tumors",
"criterions": [
{
"exact_snippets": "Colorectal tumors",
"criterion": "colorectal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Colorectal tumors",
"criterion": "colorectal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)",
"criterions": [
{
"exact_snippets": "K-ras wild-type tumors",
"criterion": "K-ras mutation status",
"requirement": {
"requirement_type": "mutation status",
"expected_value": "wild-type"
}
},
{
"exact_snippets": "inoperable lymphnode metastasis",
"criterion": "lymphnode metastasis operability",
"requirement": {
"requirement_type": "operability",
"expected_value": false
}
},
{
"exact_snippets": "after standard chemotherapy (FOLFOX, FOLFIRI)",
"criterion": "prior chemotherapy regimens",
"requirement": {
"requirement_type": "regimen",
"expected_value": [
"FOLFOX",
"FOLFIRI"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "K-ras wild-type tumors",
"criterion": "K-ras mutation status",
"requirement": {
"requirement_type": "mutation status",
"expected_value": "wild-type"
}
},
{
"exact_snippets": "inoperable lymphnode metastasis",
"criterion": "lymphnode metastasis operability",
"requirement": {
"requirement_type": "operability",
"expected_value": false
}
},
{
"exact_snippets": "after standard chemotherapy (FOLFOX, FOLFIRI)",
"criterion": "prior chemotherapy regimens",
"requirement": {
"requirement_type": "regimen",
"expected_value": [
"FOLFOX",
"FOLFIRI"
]
}
}
]
}
},
{
"identified_line": {
"line": "3. Patient Characteristics",
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"line": "* Prior treatments: Patients must have received at least one prior chemotherapeutic regimen and must be more than 1 month past the last treatment.",
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},
{
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"line": "* No concomitant use of immunosuppressive drugs, hormonal treatment for breast cancer is allowed in case of stable disease",
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"operator": "=",
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"operator": "=",
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}
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{
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],
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