{"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":"FG000","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":"FG001","title":"Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}],"type":"Pre-transplant screen failure"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Denial of insurance coverage"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Inability to collect adequate stem cells"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"70"},{"groupId":"FG001","numSubjects":"60"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"44"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"16"}],"type":"NOT COMPLETED"}],"title":"Phase I: Dose Escalation"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"denial of insurance coverage"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"42"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"34"}],"type":"Proceeded From Phase I to Phase II"},{"achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"8"}],"type":"Enrolled During Phase II"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"40"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Phase II: Treatment at MTD"}],"recruitmentDetails":"Phase I: 129 (70 Group A and 60 Group B) participants were enrolled during the Phase I portion.\n\nPhase II: 48 (40 Group A and 8 Group B) participants were enrolled during the Phase II portion.\n\nBoth Phases: 72 Phase I participants were still on study when Phase II began."}