{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"DLTs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"AE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"AEs leading to study discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"AEs leading to study treatment discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"AE leading to leading to study treatment dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Adverse events leading to study treatment dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Treatment emergent adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"Dose Limiting Toxicities are defined as events that occur during the first 28 days (Day 0 - Day 28) that meets one of the following criteria:\n\n* Any local reaction that requires operative intervention and is felt to be attributable to study drug\n* Any local reaction that has life-threatening consequences requiring urgent intervention or results in death and is felt to be attributable to study drug\n* Any Grade 3 or higher non-hematologic adverse event that is at least possibly related to study drug and lasts ≥ 3 days\n* Nausea and vomiting will not be considered a DLT unless at least Grade 3 and refractory to antiemetics\n* Grade 3 or higher thrombocytopenia (\\< 50,000/mm3) at least possibly related to study drug\n* Any Grade 4 hematologic toxicity (except thrombocytopenia) that is at least possibly related to study drug and lasts ≥ 5 days\n* Transient neurological changes are expected in Arm 2 and will not be considered a DLT unless they last \\> 10 days","groups":[{"description":"Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 1 (Pediatric Brain Tumor):\n\n* Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex\n* Actual: All patients received 1 dose level (10 mg/day veledimex)","id":"OG000","title":"Arm 1 - Closed"},{"description":"Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 2 (DIPG):\n\n* Planned:2 dose levels (10mg/day, 20mg/day)\n* Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.","id":"OG001","title":"Arm 2 - Closed"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Full Analysis Set (FAS) or the OSP includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures.\n\n• The data analysis for Adverse Events or other Safety variables will be performed on the OSP.","reportingStatus":"POSTED","timeFrame":"From Day 0 through Day 56","title":"The Safety and Tolerability of Intratumoral Ad-RTS-hIL-12 and Veledimex as Measured by Dose Limiting Toxicities and Compliance.","type":"PRIMARY","unitOfMeasure":"Participants"}