{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"2"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.","groups":[{"description":"Patients receive 1x10\\^6 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG000","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 1"},{"description":"Patients receive 1x10\\^7 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG001","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 2"},{"description":"Patients receive 1x10\\^8 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG002","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 3"},{"description":"Patients receive 1x10\\^9 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG003","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 4"},{"description":"Patients receive 1x10\\^10 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG004","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 5"},{"description":"Patients receive 1x10\\^11 MV-NIS (TCID50) IV over 1 hour on day 1.","id":"OG005","title":"Phase I: Stage 1 (MV-NIS Alone) Dose Level 6"},{"description":"Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)","id":"OG006","title":"Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1"},{"description":"Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)","id":"OG007","title":"Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2"},{"description":"Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)","id":"OG008","title":"Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Only phase I patients who completed the study are included in this analysis.","reportingStatus":"POSTED","timeFrame":"6 weeks","title":"Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}