{
    "info": {
        "nct_id": "NCT00280982",
        "official_title": "Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma",
        "inclusion_criteria": "* Patients with clinically and histological or cytological confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study.\n* Patients must be at least 18 years old and must be able to give written informed consent.\n* Patients must be ambulatory (Karnofsky scale > 70, or WHO-ECOG performance status 0,1, or 2) and in stable medical condition. The expected survival must be at least 4 months.\n* Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.5*109/l, platelet count > 100*109/l, and Hb > 6.0 mmol/l.\n* Positive delayed type hypersensitivity skin test (induration > 2mm after 48hrs) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux).\n* Stable disease or response after chemotherapy.\n* Availability of sufficient tumor material of the patient.\n* Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy.\n* Pleurodesis at the affected side before the pleural fluid is obtained.\n* Medical or psychological impediment to probable compliance with the protocol.\n* Patients on steroid (or other immunosuppressive agents) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study.\n* No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.\n* Serious concomitant disease, no active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.\n* Patients with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinators to constitute an unwarranted high risk for investigational DC treatment.\n* Patients with a known allergy to shell fish (contains KLH).\n* Pregnant or lactating women.\n* Patients with inadequate peripheral vein access to perform leukapheresis\n* Concomitant participation in another clinical trial\n* An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.\n* Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with clinically and histological or cytological confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study.",
            "criterions": [
                {
                    "exact_snippets": "clinically and histological or cytological confirmed newly diagnosed mesothelioma",
                    "criterion": "mesothelioma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "clinical",
                                "histological",
                                "cytological"
                            ]
                        },
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "can be measured in two dimensions by a radiologic imaging study",
                    "criterion": "tumor measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "two dimensions by a radiologic imaging study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years old and must be able to give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be able to give written informed consent",
                    "criterion": "ability to give written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be ambulatory (Karnofsky scale > 70, or WHO-ECOG performance status 0,1, or 2) and in stable medical condition. The expected survival must be at least 4 months.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be ambulatory (Karnofsky scale > 70 ...",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "Karnofsky scale",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be ambulatory ... WHO-ECOG performance status 0,1, or 2",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "WHO-ECOG performance status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in stable medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The expected survival must be at least 4 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.5*109/l, platelet count > 100*109/l, and Hb > 6.0 mmol/l.",
            "criterions": [
                {
                    "exact_snippets": "normal organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count > 1.5*109/l",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "*109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count > 100*109/l",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "*109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb > 6.0 mmol/l",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 6.0,
                                "unit": "mmol/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive delayed type hypersensitivity skin test (induration > 2mm after 48hrs) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux).",
            "criterions": [
                {
                    "exact_snippets": "Positive delayed type hypersensitivity skin test (induration > 2mm after 48hrs)",
                    "criterion": "delayed type hypersensitivity skin test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "induration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "against at least one positive control antigen of MULTITEST CMI (Pasteur merieux)",
                    "criterion": "positive control antigen of MULTITEST CMI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stable disease or response after chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Stable disease or response after chemotherapy",
                    "criterion": "disease status after chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "stable",
                                "response"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of sufficient tumor material of the patient.",
            "criterions": [
                {
                    "exact_snippets": "Availability of sufficient tumor material",
                    "criterion": "tumor material",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.",
            "criterions": [
                {
                    "exact_snippets": "Ability to return to the Erasmus MC for adequate follow-up",
                    "criterion": "ability to return for follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Conditions that make the patient unfit for chemotherapy",
                    "criterion": "fitness for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease after 4 cycles of chemotherapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pleurodesis at the affected side before the pleural fluid is obtained.",
            "criterions": [
                {
                    "exact_snippets": "Pleurodesis at the affected side",
                    "criterion": "pleurodesis",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "affected side"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical or psychological impediment to probable compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Medical ... impediment to probable compliance with the protocol.",
                    "criterion": "medical impediment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological impediment to probable compliance with the protocol.",
                    "criterion": "psychological impediment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on steroid (or other immunosuppressive agents) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients on steroid (or other immunosuppressive agents) are excluded",
                    "criterion": "use of steroid or other immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have had 6 weeks of discontinuation",
                    "criterion": "discontinuation of steroid or other immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must stop of any such treatment during the time of the study",
                    "criterion": "use of steroid or other immunosuppressive agents during the study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.",
            "criterions": [
                {
                    "exact_snippets": "No prior malignancy is allowed",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial or in-situ cancer of the bladder",
                    "criterion": "cancer of the bladder",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "superficial",
                                "in-situ"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer for which the patient has been disease-free for five years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious concomitant disease, no active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.",
            "criterions": [
                {
                    "exact_snippets": "Serious concomitant disease",
                    "criterion": "serious concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "history of autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "organ allografts",
                    "criterion": "organ allografts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active acute or chronic infection",
                    "criterion": "active acute or chronic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "viral hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinators to constitute an unwarranted high risk for investigational DC treatment.",
            "criterions": [
                {
                    "exact_snippets": "serious intercurrent chronic or acute illness ... pulmonary (asthma or COPD)",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious intercurrent chronic or acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious intercurrent chronic or acute illness ... cardiac (NYHA class III or IV)",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious intercurrent chronic or acute"
                        },
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "serious intercurrent chronic or acute illness ... hepatic disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious intercurrent chronic or acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious intercurrent chronic or acute illness ... other illness considered by the study coordinators to constitute an unwarranted high risk",
                    "criterion": "other illness",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "unwarranted high risk for investigational DC treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a known allergy to shell fish (contains KLH).",
            "criterions": [
                {
                    "exact_snippets": "known allergy to shell fish",
                    "criterion": "allergy to shell fish",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with inadequate peripheral vein access to perform leukapheresis",
            "criterions": [
                {
                    "exact_snippets": "inadequate peripheral vein access",
                    "criterion": "peripheral vein access",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "perform leukapheresis",
                    "criterion": "ability to perform leukapheresis",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant participation in another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Concomitant participation in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "concomitant",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.",
            "criterions": [
                {
                    "exact_snippets": "An organic brain syndrome",
                    "criterion": "organic brain syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant psychiatric abnormality",
                    "criterion": "significant psychiatric abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.",
            "criterions": [
                {
                    "exact_snippets": "Absence of assurance of compliance with the protocol",
                    "criterion": "compliance with the protocol",
                    "requirements": [
                        {
                            "requirement_type": "assurance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of availability for follow-up assessment",
                    "criterion": "availability for follow-up assessment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}