{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T15:36:32Z","timestamp":1790696192819,"version":"4.1.0"},"reference-count":34,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>In this clinical trial report, the authors analyze safety and infusion distribution of IL13-<jats:italic>Pseudomonas<\/jats:italic> exotoxin, an antitumor chimeric molecule, administered via intratumoral convection enhanced delivery (CED) in pediatric patients with diffuse intrinsic pontine glioma (DIPG).<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>This was a Phase I single-institution, open-label, dose-escalation, safety and tolerability study of IL13-PE38QQR infused via single-catheter CED into 5 pediatric DIPG patients. IL13-PE38QQR was administered to regions of tumor selected by radiographic findings. Two escalating dose levels were evaluated: 0.125 \u00b5g\/mL in cohort 1 and 0.25 \u00b5g\/mL in cohort 2. Real-time MRI was performed during intratumoral infusions, and MRI and MR spectroscopy were performed before and after the infusions. Clinical evaluations, including parent-reported quality of life (QOL), were assessed at baseline and 4 weeks post-infusion.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Direct infusion of brainstem tumor with IL13-PE using the CED technique in patients with DIPG produced temporary arrest of disease progression in 2 of 5 patients, both of whom subsequently received a second infusion. All 5 patients showed signs of disease progression by 12 weeks after initial infusion. Two patients experienced transient cranial nerve deficits and lethargy after infusion, and these deficits resolved with corticosteroid treatment in both cases. No patient had radiographic evidence of acute or long-term treatment toxicity. Parent-reported QOL was consistent with medical outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Even though IL13-PE delivered by CED did not reach the entire MRI-defined tumor volume in any patient, short-term radiographic antitumor effects were observed in 2 of the 5 patients treated. The patients\u2019 performance status did not improve. Drug delivery using multiple catheters may produce improved outcomes.<\/jats:p><jats:p>Clinical trial registration no.: NCT00088061 (clinicaltrials.gov)<\/jats:p><\/jats:sec>","DOI":"10.3171\/2018.9.peds17225","type":"journal-article","created":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T00:51:48Z","timestamp":1551228708000},"page":"333-342","source":"Crossref","is-referenced-by-count":69,"title":["Phase I trial of convection-enhanced delivery of IL13-Pseudomonas toxin in children with diffuse intrinsic pontine glioma"],"prefix":"10.3171","volume":"23","author":[{"given":"John D.","family":"Heiss","sequence":"first","affiliation":[{"name":"Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aria","family":"Jamshidi","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, Florida;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Smit","family":"Shah","sequence":"additional","affiliation":[{"name":"Rutgers University Robert Wood Johnson Medical School, Piscataway, New Jersey; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Staci","family":"Martin","sequence":"additional","affiliation":[{"name":"Center for Cancer Research and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela L.","family":"Wolters","sequence":"additional","affiliation":[{"name":"Center for Cancer Research and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davis P.","family":"Argersinger","sequence":"additional","affiliation":[{"name":"Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine E.","family":"Warren","sequence":"additional","affiliation":[{"name":"Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell R.","family":"Lonser","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Ohio State University Wexner Medical Center, Columbus, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1","series-title":"Neurosurgery","first-page":"1026","article-title":"Magnetic resonance scans should replace biopsies for the diagnosis of diffuse brain stem gliomas: a report from the Children\u2019s Cancer Group","volume":"33","author":"Albright AL","year":"1993","unstructured":"Albright AL, Packer RJ, Zimmerman R, Rorke LB, Boyett J, Hammond GD: Magnetic resonance scans should replace biopsies for the diagnosis of diffuse brain stem gliomas: a report from the Children\u2019s Cancer Group. 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