{
    "info": {
        "nct_id": "NCT00525031",
        "official_title": "Randomized Phase II Neoadjuvant Study of Temozolomide Alone or With Pegylated Interferon-alpha 2b in Patients With Resectable American Joint Committee on Cancer (AJCC) Stage IIIB/IIIC or Stage IV (M1a) Metastatic Melanoma",
        "inclusion_criteria": "1. Histologically documented diagnosis of melanoma metastases.\n2. Stage IIIB/IIIC (N2b, N2c and N3) or stage IV (M1a) melanoma patients with measurable and potentially resectable metastases without clinical and radiological evidence of other distant metastases.\n3. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Age 18 or older.\n5. Adequate organ function defined as follows: a.) Absolute granulocytes greater than or equal to 1,000/mm^3 and Platelets greater than or equal to 100,000/mm^3, b.) Serum bilirubin and serum creatinine of less than or equal to 1.5 times upper limit of laboratory normal. If serum creatinine is greater than 1.5 times upper limit of laboratory normal, the urine creatinine clearance must be greater than 60 ml/min., c.) serum glutamate oxaloacetate transaminase (SGOT) (AST), serum glutamate pyruvate transaminase (SGPT) (ALT) and alkaline phosphatase less than or equal to 3 times upper limit of laboratory normal.\n6. Patients have not had any previous systemic chemotherapy for metastatic melanoma. Prior biologic therapy, targeted therapy or immunotherapy are allowable, but must be at least 2 weeks since prior therapy before starting study drugs. No other concurrent chemotherapy, immunotherapy, or radiotherapy.\n7. Prior radiation therapy used to enhance local regional control is permitted, but must be at least 2 weeks since prior therapy before starting study drugs. In addition, the patient must have unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity. Lesions within the prior field of radiation may only be used as indicator lesions if there has been recent evidence of disease progression after .\n8. Ability to understand and sign an informed consent form, indicating awareness of the investigational nature of this study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Significant cardiac or pulmonary dysfunction, such as a history of severe cardiovascular disease, myocardial infarction within 6 months of the start of treatment, unstable angina, Class III or Class IV congestive heart failure, ventricular arrhythmia, or any uncontrolled arrhythmia.\n2. Current significant psychiatric illness.\n3. Serious infection requiring intravenous antibiotics, or any non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by complications of this therapy.\n4. Frequent vomiting or any medical condition (e.g. partial bowel obstruction) that could interfere with oral medication intake.\n5. Autoimmune or immunosuppressive disorders (e.g. HIV or AIDS-related illness).\n6. Patients who require therapy with systemic corticosteroids.\n7. No evidence of active secondary malignancy that requires chemotherapy within the past 2 years (excluding non-melanoma skin cancer, and/or all carcinoma in-situ)\n8. Pregnant or lactating women are ineligible. Women of childbearing potential must have a negative urine pregnancy test within a week of initiation of therapy. All patients must agree to use medically approved contraceptive measures to prevent pregnancy during treatment.\n9. Any other medical condition or reason that, in the principal investigator's opinion, makes the patient unsuitable to participate in a clinical trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically documented diagnosis of melanoma metastases.",
            "criterions": [
                {
                    "exact_snippets": "Histologically documented diagnosis of melanoma metastases",
                    "criterion": "melanoma metastases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically documented"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Stage IIIB/IIIC (N2b, N2c and N3) or stage IV (M1a) melanoma patients with measurable and potentially resectable metastases without clinical and radiological evidence of other distant metastases.",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIB/IIIC (N2b, N2c and N3) or stage IV (M1a) melanoma",
                    "criterion": "melanoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IIIC",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable and potentially resectable metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": "potentially"
                        }
                    ]
                },
                {
                    "exact_snippets": "without clinical and radiological evidence of other distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 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"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age 18 or older.",
            "criterions": [
                {
                    "exact_snippets": "Age 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate organ function defined as follows: a.) Absolute granulocytes greater than or equal to 1,000/mm^3 and Platelets greater than or equal to 100,000/mm^3, b.) Serum bilirubin and serum creatinine of less than or equal to 1.5 times upper limit of laboratory normal. If serum creatinine is greater than 1.5 times upper limit of laboratory normal, the urine creatinine clearance must be greater than 60 ml/min., c.) serum glutamate oxaloacetate transaminase (SGOT) (AST), serum glutamate pyruvate transaminase (SGPT) (ALT) and alkaline phosphatase less than or equal to 3 times upper limit of laboratory normal.",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocytes greater than or equal to 1,000/mm^3",
                    "criterion": "absolute granulocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets greater than or equal to 100,000/mm^3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum bilirubin ... less than or equal to 1.5 times upper limit of laboratory normal",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limit of laboratory normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ... less than or equal to 1.5 times upper limit of laboratory normal",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limit of laboratory normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine is greater than 1.5 times upper limit of laboratory normal, the urine creatinine clearance must be greater than 60 ml/min.",
                    "criterion": "urine creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum glutamate oxaloacetate transaminase (SGOT) (AST) ... less than or equal to 3 times upper limit of laboratory normal",
                    "criterion": "serum glutamate oxaloacetate transaminase (SGOT) (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times upper limit of laboratory normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum glutamate pyruvate transaminase (SGPT) (ALT) ... less than or equal to 3 times upper limit of laboratory normal",
                    "criterion": "serum glutamate pyruvate transaminase (SGPT) (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times upper limit of laboratory normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase less than or equal to 3 times upper limit of laboratory normal",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times upper limit of laboratory normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients have not had any previous systemic chemotherapy for metastatic melanoma. Prior biologic therapy, targeted therapy or immunotherapy are allowable, but must be at least 2 weeks since prior therapy before starting study drugs. No other concurrent chemotherapy, immunotherapy, or radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients have not had any previous systemic chemotherapy for metastatic melanoma.",
                    "criterion": "previous systemic chemotherapy for metastatic melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior biologic therapy, targeted therapy or immunotherapy are allowable, but must be at least 2 weeks since prior therapy before starting study drugs.",
                    "criterion": "prior biologic therapy, targeted therapy or immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent chemotherapy, immunotherapy, or radiotherapy.",
                    "criterion": "concurrent chemotherapy, immunotherapy, or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Prior radiation therapy used to enhance local regional control is permitted, but must be at least 2 weeks since prior therapy before starting study drugs. In addition, the patient must have unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity. Lesions within the prior field of radiation may only be used as indicator lesions if there has been recent evidence of disease progression after .",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy used to enhance local regional control is permitted",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "enhance local regional control"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be at least 2 weeks since prior therapy before starting study drugs",
                    "criterion": "time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patient must have unirradiated metastatic sites for response evaluation",
                    "criterion": "unirradiated metastatic sites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has fully recovered from its toxicity",
                    "criterion": "recovery from toxicity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fully recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions within the prior field of radiation may only be used as indicator lesions if there has been recent evidence of disease progression",
                    "criterion": "lesions within the prior field of radiation",
                    "requirements": [
                        {
                            "requirement_type": "use as indicator lesions",
                            "expected_value": "if recent evidence of disease progression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Ability to understand and sign an informed consent form, indicating awareness of the investigational nature of this study.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign an informed consent form",
                    "criterion": "consent capability",
                    "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": "1. Significant cardiac or pulmonary dysfunction, such as a history of severe cardiovascular disease, myocardial infarction within 6 months of the start of treatment, unstable angina, Class III or Class IV congestive heart failure, ventricular arrhythmia, or any uncontrolled arrhythmia.",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiac or pulmonary dysfunction",
                    "criterion": "cardiac or pulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months of the start of treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Class III or Class IV congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Current significant psychiatric illness.",
            "criterions": [
                {
                    "exact_snippets": "Current significant psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "current"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Serious infection requiring intravenous antibiotics, or any non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by complications of this therapy.",
            "criterions": [
                {
                    "exact_snippets": "Serious infection requiring intravenous antibiotics",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous antibiotics"
                        }
                    ]
                },
                {
                    "exact_snippets": "any non-malignant medical illnesses that are uncontrolled",
                    "criterion": "non-malignant medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "any non-malignant medical illnesses ... whose control may be jeopardized by complications of this therapy",
                    "criterion": "non-malignant medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "jeopardized by complications of this therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Frequent vomiting or any medical condition (e.g. partial bowel obstruction) that could interfere with oral medication intake.",
            "criterions": [
                {
                    "exact_snippets": "Frequent vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "frequent"
                        }
                    ]
                },
                {
                    "exact_snippets": "any medical condition (e.g. partial bowel obstruction) that could interfere with oral medication intake",
                    "criterion": "medical condition interfering with oral medication intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Autoimmune or immunosuppressive disorders (e.g. HIV or AIDS-related illness).",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune or immunosuppressive disorders",
                    "criterion": "autoimmune or immunosuppressive disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV or AIDS-related illness",
                    "criterion": "HIV or AIDS-related illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who require therapy with systemic corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Patients who require therapy with systemic corticosteroids",
                    "criterion": "systemic corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. No evidence of active secondary malignancy that requires chemotherapy within the past 2 years (excluding non-melanoma skin cancer, and/or all carcinoma in-situ)",
            "criterions": [
                {
                    "exact_snippets": "No evidence of active secondary malignancy",
                    "criterion": "active secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requires chemotherapy within the past 2 years",
                    "criterion": "chemotherapy requirement for secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding non-melanoma skin cancer, and/or all carcinoma in-situ",
                    "criterion": "type of secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "carcinoma in-situ"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnant or lactating women are ineligible. Women of childbearing potential must have a negative urine pregnancy test within a week of initiation of therapy. All patients must agree to use medically approved contraceptive measures to prevent pregnancy during treatment.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women are ineligible.",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or lactating women are ineligible.",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential must have a negative urine pregnancy test within a week of initiation of therapy.",
                    "criterion": "urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "All patients must agree to use medically approved contraceptive measures to prevent pregnancy during treatment.",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Any other medical condition or reason that, in the principal investigator's opinion, makes the patient unsuitable to participate in a clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Any other medical condition or reason ... makes the patient unsuitable to participate",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion of principal investigator",
                            "expected_value": "suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}