{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T01:16:45Z","timestamp":1791422205070,"version":"4.3.3"},"reference-count":51,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"14","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2014,5,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>The addition of immunotherapy, including a combination of anti-GD2 monoclonal antibody (mAb), ch14.18, and cytokines, improves outcome for patients with high-risk neuroblastoma. However, this therapy is limited by ch14.18-related toxicities that may be partially mediated by complement activation. We report the results of a phase I trial to determine the maximum-tolerated dose (MTD), safety profile, and pharmacokinetics of hu14.18K322A, a humanized anti-GD2 mAb with a single point mutation (K322A) that reduces complement-dependent lysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>Eligible patients with refractory or recurrent neuroblastoma received escalating doses of hu14.18K322A ranging from 2 to 70 mg\/m<jats:sup>2<\/jats:sup>per day for 4 consecutive days every 28 days (one course).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty-eight patients (23 males; median age, 7.2 years) received a median of two courses (range, one to 15). Dose-limiting grade 3 or 4 toxicities occurred in four of 36 evaluable patients and were characterized by cough, asthenia, sensory neuropathy, anorexia, serum sickness, and hypertensive encephalopathy. The most common non\u2013dose-limiting grade 3 or 4 toxicities during course one were pain (68%) and fever (21%). Six of 31 patients evaluable for response by iodine-123 metaiodobenzylguanidine score had objective responses (four complete responses; two partial responses). The first-course pharmacokinetics of hu14.18K322A were best described by a two-compartment linear model. Median hu14.18K322A \u03b1 (initial phase) and \u03b2 (terminal phase) half-lives were 1.74 and 21.1 days, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The MTD, and recommended phase II dose, of hu14.18K322A is 60 mg\/m<jats:sup>2<\/jats:sup>per day for 4 days. Adverse effects, predominately pain, were manageable and improved with subsequent courses.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2013.50.4423","type":"journal-article","created":{"date-parts":[[2014,4,8]],"date-time":"2014-04-08T04:11:02Z","timestamp":1396930262000},"page":"1445-1452","source":"Crossref","is-referenced-by-count":153,"title":["Phase I Trial of a Novel Anti-GD2 Monoclonal Antibody, Hu14.18K322A, Designed to Decrease Toxicity in Children With Refractory or Recurrent Neuroblastoma"],"prefix":"10.1200","volume":"32","author":[{"given":"Fariba","family":"Navid","sequence":"first","affiliation":[{"name":"Fariba Navid, Barry L. Shulkin, Robert A. Kaufman, Catherine A. Billups, Jianrong Wu, Wayne L. Furman, Lisa M. McGregor, and Victor M. Santana, St Jude Children's Research Hospital; Fariba Navid, Robert A. Kaufman, Wayne L. Furman, Lisa M. McGregor, and Victor M. Santana, College of Medicine, University of Tennessee Health Science Center; Jim A. 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