{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"6"}],"units":"Participants"}],"description":"This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.\n\n\\> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.\n\n\\> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here.","groups":[{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8","id":"OG000","title":"Treatment: Trial 1, Dose Level 1"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8","id":"OG001","title":"Treatment: Trial 1, Dose Level 2"},{"description":"Patients receive:\n\nCycle 1:\n\n50 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.","id":"OG002","title":"Treatment: Trial 2, Dose Level 3"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.","id":"OG003","title":"Treatment: Trial 2, Dose Level 4"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.","id":"OG004","title":"Treatment: Trial 3, Dose Level 5"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.","id":"OG005","title":"Treatment: Trial 3, Dose Level 6"}],"paramType":"NUMBER","populationDescription":"DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.","reportingStatus":"POSTED","timeFrame":"At 8 weeks","title":"Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)","type":"PRIMARY","unitOfMeasure":"Patients reporting Dose-Limiting Events"}