{
    "info": {
        "nct_id": "NCT00626860",
        "official_title": "The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma",
        "inclusion_criteria": "* patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment\n* Patients must be at least 18 years old\n* Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy\n* Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.\n* Labs: WBC >_ 2.0 x 10x3/uL, Bilirubin <_2.0 mg/dL, Creatine <_ 2.0mg/dL\n* Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented\n* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry\n* Patients must not have received chemotherapy for three weeks prior to the first vaccination\n* Patients must be without evidence of active CNS disease\n* Patients must not have clinically significant autoimmune disease\n* Patients must be HIV negative\n* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure\n* Patients requiring corticosteroids for either melanoma related or co-morbid illness",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be at least 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than 9 week life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.",
            "criterions": [
                {
                    "exact_snippets": "accessible tumor ... soft tissue, bone marrow or visceral lesions",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "soft tissue",
                                "bone marrow",
                                "visceral lesions"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia",
                    "criterion": "tumor resection under local anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "not significantly invasive"
                        },
                        {
                            "requirement_type": "anesthesia",
                            "expected_value": "general"
                        }
                    ]
                },
                {
                    "exact_snippets": "Malignant ascites or pleural effusion",
                    "criterion": "malignant fluid accumulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients requiring major surgical intervention will be considered ineligible",
                    "criterion": "major surgical intervention",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study",
                    "criterion": "tumor resection for independent indications",
                    "requirements": [
                        {
                            "requirement_type": "schedule",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Labs: WBC >_ 2.0 x 10x3/uL, Bilirubin <_2.0 mg/dL, Creatine <_ 2.0mg/dL",
            "criterions": [
                {
                    "exact_snippets": "WBC >_ 2.0 x 10x3/uL",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "x 10x3/uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin <_2.0 mg/dL",
                    "criterion": "Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatine <_ 2.0mg/dL",
                    "criterion": "Creatine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing age",
                    "criterion": "childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate contraception method(s) must be documented",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines",
            "criterions": [
                {
                    "exact_snippets": "All patients must be informed of the investigational nature of this study",
                    "criterion": "patient information",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have received chemotherapy for three weeks prior to the first vaccination",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have received chemotherapy for three weeks prior to the first vaccination",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be without evidence of active CNS disease",
            "criterions": [
                {
                    "exact_snippets": "without evidence of active CNS disease",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have clinically significant autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "clinically significant autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be HIV negative",
            "criterions": [
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "serious intercurrent illness such as infection requiring IV antibiotics",
                    "criterion": "serious intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by significant arrhythmia",
                    "criterion": "significant arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by ... ischemic coronary disease",
                    "criterion": "ischemic coronary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac disease characterized by ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients requiring corticosteroids for either melanoma related or co-morbid illness",
            "criterions": [
                {
                    "exact_snippets": "Patients requiring corticosteroids for either melanoma related",
                    "criterion": "corticosteroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "melanoma related"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients requiring corticosteroids for ... co-morbid illness",
                    "criterion": "corticosteroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "co-morbid illness"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnoses of disseminated melanoma",
                    "criterion": "disseminated melanoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable ... metastatic involvement",
                    "criterion": "metastatic involvement",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clearly progressive metastatic involvement",
                    "criterion": "metastatic involvement",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "clearly progressive"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}