{"denoms":[{"counts":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"177"}],"units":"Participants"}],"groups":[{"description":"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.\n\nmelphalan: (Days -4,-3,-2) 50 mg/m\\^2/day IV over 30 minutes (total dose 150 mg/m\\^2)\n\ntopotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\\^2; Level 2 - 30 mg/m\\^2; Level 4 - 54 mg/m\\^2; Level 5 - 72 mg/m\\^2; Level 6 - 96 mg/m\\^2; Level 7 - 127.8 mg/m\\^2; Level 8 - 170.1 mg/m\\^2\n\nPhase II: Treatment at maximum tolerated dose (MTD)\n\nAutologous Stem Cell Rescue: Day 0","id":"BG000","title":"Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue"},{"description":"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.\n\nmelphalan: (Days -4,-3,-2) 50 mg/m\\^2/day IV over 30 minutes (total dose 150 mg/m\\^2)\n\ntopotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\\^2; Level 2 - 30 mg/m\\^2; Level 4 - 54 mg/m\\^2; Level 5 - 72 mg/m\\^2; Level 6 - 96 mg/m\\^2; Level 7 - 127.8 mg/m\\^2; Level 8 - 170.1 mg/m\\^2\n\nPhase II: Treatment at maximum tolerated dose (MTD)\n\nAutologous Stem Cell Rescue: Day 0","id":"BG001","title":"Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"32","upperLimit":"60","value":"46"},{"groupId":"BG001","lowerLimit":"61","upperLimit":"76","value":"68.5"},{"groupId":"BG002","lowerLimit":"32","upperLimit":"76","value":"54"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"119"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"58"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"68"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"109"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"177"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"Participants: 177 included in Baseline; 129 included in Phase I Maximum Tolerated Dose Outcome; 51 Phase II participants with responsive disease prior to transplant were re-evaluated for the Overall Response Rate; 79 treated in Phase II and evaluable at time of analysis are included in the Event Free Survival and Overall Survival Outcome Measures."}