{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment.\\>\n\n\\> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\\>\n\n* grade 4 toxicity for neutrophils (\\<0.5 x 109/L) or platelets (\\<25 x 109/L)\\>\n* any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\\>\n* more than 10 x ULN AST toxicity for more than 14 days\\>\n* any grade 4 infection.\\>\n\nThe number of patients who reported a dose limiting toxicity is reported here.","groups":[{"description":"Dose Level 1= 0.15 mg/kg\\> Each cycle is 4 weeks.\\> \\> Cycle 1 and 2:\\> Alefacept by IV Weekly\\>\n\n\\> Cycles 3-12:\\> Alefacept by IV 1 x every 4 weeks","id":"OG000","title":"Dose Level 1"},{"description":"Dose Level 2= 0.20 mg/kg\\> Each cycle is 4 weeks.\\> \\> Cycle 1 and 2:\\> Alefacept by IV Weekly\\>\n\n\\> Cycles 3-12:\\> Alefacept by IV 1 x every 4 weeks","id":"OG001","title":"Dose Level 2"},{"description":"Dose Level 3= 0.30 mg/kg\\> Each cycle is 4 weeks.\\> \\> Cycle 1 and 2:\\> Alefacept by IV Weekly\\>\n\n\\> Cycles 3-12:\\> Alefacept by IV 1 x every 4 weeks","id":"OG002","title":"Dose Level 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.","reportingStatus":"POSTED","timeFrame":"8 weeks from registration","title":"Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}