{
    "info": {
        "nct_id": "NCT00141765",
        "official_title": "Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers",
        "inclusion_criteria": "* Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:\n\n  1. is metastatic and has < 25% cure rate with conventional treatment; or\n  2. progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies.\n* Disease status: Within 3 weeks of initiation of this protocol, patients must:\n\n  1. be in a complete or good partial remission (section 7.4); or\n  2. have a \"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.\n* Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:\n\n  1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or\n  2. courses of high-dose ifosfamide totaling > 12 gm/m2.\n  3. 1 course of \"a)\" above, plus 1 course of 'b)\" above.\n  4. Equivalent high dose alkylating agents as described in 3.3 a, b, and c.\n* Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).\n* Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):\n\n  1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,\n  2. Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.\n* Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program\nHealthy volunteers allowed\nMust have maximum age of 21 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:",
            "criterions": [
                {
                    "exact_snippets": "ineligible for other IRB-approved myeloablative regimens",
                    "criterion": "eligibility for other IRB-approved myeloablative regimens",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "21 years old or younger",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "Wilms' tumor",
                                "liver cancer",
                                "recurrent brain tumor of childhood",
                                "nasopharyngeal carcinoma",
                                "fibrosarcoma",
                                "desmoplastic small round cell tumor",
                                "germ cell tumor",
                                "other small round cell tumor"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. is metastatic and has < 25% cure rate with conventional treatment; or",
            "criterions": [
                {
                    "exact_snippets": "is metastatic",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "< 25% cure rate with conventional treatment",
                    "criterion": "cure rate with conventional treatment",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies.",
            "criterions": [
                {
                    "exact_snippets": "progressed after prior chemotherapy",
                    "criterion": "progression after chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "< 25% salvage rate with non-myeloablative therapies",
                    "criterion": "salvage rate with non-myeloablative therapies",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease status: Within 3 weeks of initiation of this protocol, patients must:",
            "criterions": [
                {
                    "exact_snippets": "Disease status: Within 3 weeks of initiation of this protocol",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. be in a complete or good partial remission (section 7.4); or",
            "criterions": [
                {
                    "exact_snippets": "be in a complete or good partial remission",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "complete remission",
                                "good partial remission"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. have a \"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.",
            "criterions": [
                {
                    "exact_snippets": "\"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy",
                    "criterion": "chemosensitive tumor",
                    "requirements": [
                        {
                            "requirement_type": "response to chemotherapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "progressive disease",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "benefit",
                            "expected_value": "maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue.",
                    "criterion": "conventional therapy",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": [
                                "complete remission",
                                "no further benefit",
                                "toxicity perceived as limiting"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "The cancer must be proven to be sensitive to alkylating agents.",
                    "criterion": "cancer sensitivity to alkylating agents",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or",
            "criterions": [
                {
                    "exact_snippets": "2 courses of high-dose cyclophosphamide",
                    "criterion": "cyclophosphamide treatment",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "totaling > 4200 mg/m2",
                    "criterion": "cumulative cyclophosphamide dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 4200,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. courses of high-dose ifosfamide totaling > 12 gm/m2.",
            "criterions": [
                {
                    "exact_snippets": "courses of high-dose ifosfamide totaling > 12 gm/m2",
                    "criterion": "ifosfamide dosage",
                    "requirements": [
                        {
                            "requirement_type": "total dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "gm/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 1 course of \"a)\" above, plus 1 course of 'b)\" above.",
            "criterions": [
                {
                    "exact_snippets": "1 course of \"a)\" above",
                    "criterion": "treatment course a",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "1 course of 'b)\" above",
                    "criterion": "treatment course b",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Equivalent high dose alkylating agents as described in 3.3 a, b, and c.",
            "criterions": [
                {
                    "exact_snippets": "Equivalent high dose alkylating agents",
                    "criterion": "alkylating agents",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "equivalence",
                            "expected_value": "as described in 3.3 a, b, and c"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).",
            "criterions": [
                {
                    "exact_snippets": "adequate renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):",
            "criterions": [
                {
                    "exact_snippets": "Peripheral blood collection is to be preferred when available as an option",
                    "criterion": "peripheral blood collection",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "preferred when available"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,",
            "criterions": [
                {
                    "exact_snippets": "Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight",
                    "criterion": "nucleated cells in harvested bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000000.0,
                                "unit": "nucleated cells per kg of body weight"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.",
            "criterions": [
                {
                    "exact_snippets": "Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.",
                    "criterion": "CD34+ cells in peripheral blood",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "x 10^6 cells/kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program",
            "criterions": [
                {
                    "exact_snippets": "Informed consent must be signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating patient and/or parental awareness of the investigational nature of this program",
                    "criterion": "awareness of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "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 maximum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}