{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.","groups":[{"description":"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle\n\nZolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)\n\nDoxorubicin : 50 mg/m\\^2 by vein over 15 minutes on Day 1 of 21 day cycle\n\nPrednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle\n\nCyclophosphamide : 750 mg/m\\^2 by vein over 1 hour on Day 1 of 21 day cycle\n\nVincristine : 1.4 mg/m\\^2 by vein over 15 minutes on Day 1 of 21 day cycle","id":"OG000","title":"Schedule A - Vorinostat Once Daily"},{"description":"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle\n\nZolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)\n\nDoxorubicin : 50 mg/m\\^2 by vein over 15 minutes on Day 1 of 21 day cycle\n\nPrednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle\n\nCyclophosphamide : 750 mg/m\\^2 by vein over 1 hour on Day 1 of 21 day cycle\n\nVincristine : 1.4 mg/m\\^2 by vein over 15 minutes on Day 1 of 21 day cycle","id":"OG001","title":"Schedule A - Vorinostat Twice Daily"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"21 Days","title":"Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat","type":"PRIMARY","unitOfMeasure":"participants"}