{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:11:42Z","timestamp":1792069902202,"version":"4.4.0"},"reference-count":44,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"36","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2020,12,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Desmoplastic small round cell tumor (DSRCT), a rare sarcoma of adolescents\/young adults primarily involving the peritoneum, has a long-term survival of &lt; 20% despite aggressive multimodality treatment. B7H3 is expressed on DSRCT cell surface, providing a target for antibody-based immunotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>\n                      In this phase I study, we evaluated the safety, pharmacokinetics, and biodistribution of intraperitoneal (IP) radioimmunotherapy (RIT) with the anti-B7H3 murine monoclonal antibody\n                      <jats:sup>131<\/jats:sup>\n                      I-omburtamab in patients with DSRCT or other B7H3-expressing tumors involving the peritoneum. After thyroid blockade, patients received\n                      <jats:sup>131<\/jats:sup>\n                      I-omburtamab as a single IP injection at escalated activities from 1.11 to 3.33\/GBq\/m\n                      <jats:sup>2<\/jats:sup>\n                      . A prior tracer dose of IP 74 MBq\n                      <jats:sup>124<\/jats:sup>\n                      I-omburtamab was used for radioimmuno\u2013positron emission tomography imaging. Each injection was followed by IP saline infusion.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Fifty-two patients (48, three, and one with DSRCT, peritoneal rhabdomyosarcoma, and Ewing sarcoma, respectively) received IP\n                      <jats:sup>131<\/jats:sup>\n                      I-omburtamab administered on an outpatient basis. Maximum tolerated dose was not reached; there were no dose-limiting toxicities. Major related adverse events were transient: grade 4 neutropenia (n = 2 patients) and thrombocytopenia (n = 1), and grade 1 (10%) and grade 2 (52%) pain lasting &lt; 2 hours related to saline infusion. Hypothyroidism was not observed, and antidrug antibody was elicited in 5%. Mean (\u00b1 SD) projected peritoneal residence time was 22.4 \u00b1 7.9 hours. Mean projected absorbed doses for\n                      <jats:sup>131<\/jats:sup>\n                      I-omburtamab based on\n                      <jats:sup>124<\/jats:sup>\n                      I-omburtamab dosimetry to normal organs were low and well within tolerable limits. More than 80%\n                      <jats:sup>131<\/jats:sup>\n                      I remained protein bound in blood 66 hours after RIT. On the basis of peritoneal dose and feasibility for outpatient administration, the recommended phase II activity was established at 2.96 GBq\/m\n                      <jats:sup>2<\/jats:sup>\n                      . Patients with DSRCT receiving standard whole-abdominal radiotherapy after RIT did not experience unexpected toxicity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>\n                      IP RIT\n                      <jats:sup>131<\/jats:sup>\n                      I-omburtamab was well tolerated with minimal toxicities. Radiation exposure to normal organs was low, making combination therapy with other anticancer therapies feasible.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.20.01974","type":"journal-article","created":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T15:59:28Z","timestamp":1603987168000},"page":"4283-4291","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":79,"title":["B7H3-Directed Intraperitoneal Radioimmunotherapy With Radioiodinated Omburtamab for Desmoplastic Small Round Cell Tumor and Other Peritoneal Tumors: Results of a Phase I Study"],"prefix":"10.1200","volume":"38","clinical-trial-number":[{"clinical-trial-number":"nct01099644","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Shakeel","family":"Modak","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, 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