{"denoms":[{"counts":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"68"}],"units":"Participants"}],"groups":[{"description":"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.\n\nerlotinib: Given orally\n\ntemsirolimus: Given IV","id":"BG000","title":"Phase I n=9"},{"description":"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.\n\nAnaplastic Glioma\n\nerlotinib: Given orally\n\ntemsirolimus: Given IV","id":"BG001","title":"Phase II n=16"},{"description":"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.\n\nGlioblastoma\n\nerlotinib: Given orally\n\ntemsirolimus: Given IV","id":"BG002","title":"Phase II n=43"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"33","upperLimit":"74","value":"57"},{"groupId":"BG001","lowerLimit":"29","upperLimit":"72","value":"47"},{"groupId":"BG002","lowerLimit":"20","upperLimit":"69","value":"50"},{"groupId":"BG003","lowerLimit":"20","upperLimit":"74","value":"51"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"20"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"48"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"70","upperLimit":"100","value":"90"},{"groupId":"BG001","lowerLimit":"60","upperLimit":"100","value":"90"},{"groupId":"BG002","lowerLimit":"60","upperLimit":"100","value":"90"},{"groupId":"BG003","lowerLimit":"60","upperLimit":"100","value":"90"}]}]}],"description":"The KPS scores range from 0 (lowest score) to 100 (highest score).\n\nThe higher the score the better able to carry out daily activities\n\n100-80: able to carry on normal activity and to work; No special care\n\n70-50: Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed\n\n40-10: unable to care for self, requires equivalent of institutional or hospital care; diseases may be progressing rapidly\n\n0: dead","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Karnofsky Performance Scale (KPS)","unitOfMeasure":"units on a scale"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0","upperLimit":"3","value":"2"},{"groupId":"BG001","lowerLimit":"1","upperLimit":"3","value":"1"},{"groupId":"BG002","lowerLimit":"0","upperLimit":"3","value":"1"},{"groupId":"BG003","lowerLimit":"0","upperLimit":"3","value":"1"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Prior Chemotherapy treatments","unitOfMeasure":"treatments"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"19"}]}],"title":"anaplastic glioma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"49"}]}],"title":"glioblastoma"}],"paramType":"NUMBER","title":"Histology","unitOfMeasure":"participants"}],"populationDescription":"pts had to meet eligibility criteria and recieve at least one dose of treatment.\n\n22 eligible pts enrolled in phase 1, but 1 pt declined before starting any treatment and was excluded from analysis - 12 pts were treated at MTD and thus included in the Phase 2 analysis, hence only 9 patients remained for analysis for phase 1"}