{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"}],"title":"Number of patients that did not experience DLT"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}],"title":"Number of patient that did experience DLT"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"3"}],"units":"Participants"}],"description":"The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. All these analyses will be descriptive and exploratory and hypotheses generating in nature.","groups":[{"description":"This is the starting dose of temsirolimus at 7.5 mg/m\\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"OG000","title":"Dose Level 1"},{"description":"If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"OG001","title":"Dose Level 2"},{"description":"If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"OG002","title":"Dose Level 3"},{"description":"If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"OG003","title":"Dose Level 4"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Number of patients that initiated and completed study treatment.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)","title":"Number of Patients That Experienced DLT During Cycle 1 of Therapy","type":"PRIMARY","unitOfMeasure":"Participants"}