{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"300"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. 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); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).","groups":[{"description":"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) 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 B - Vorinostat Three Times Daily"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"21 Days","title":"Phase II MTD of Vorinostat","type":"PRIMARY","unitOfMeasure":"mg/three times daily"}