{"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":"FG000","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":"FG001","title":"Arm 2 - Closed"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Treated With Ad-RTS-hIL-12 Injection"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Treated With Veledimex"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Did Not Receive Veledimex Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Received Veledimex Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All subjects in Arm 1 received 10mg daily of veledimex. A total of three subjects were assigned to Arm 2. One subject withdrew consent prior to any study procedures on Day 0 and received no treatment. A second subject was discontinued from the study due to a Serious Adverse Event (SAE) after the Ad-RTS-hIL-12 injection but prior to receiving veledimex. The third subject received veledimex at a dose of 5 mg/day, which was the body surface area (BSA)-adjusted dose.","recruitmentDetails":"One Arm 2 subject was screened and enrolled but consent was withdrawn prior to Day 0."}