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Antitumor activity of hu14.18-IL2 in patients with relapsed/refractory neuroblastoma: a Children's Oncology Group (COG) phase II study

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dc.contributor.author Maris, JM
dc.contributor.author Reisfeld, RA
dc.contributor.author Gadbaw, B
dc.contributor.author Hecht, T
dc.contributor.author Cohn, SL
dc.contributor.author DeSantes, KB
dc.contributor.author Eickhoff, J
dc.contributor.author Gan, J
dc.contributor.author Wagner, B
dc.contributor.author Albertini, MR
dc.contributor.author Kimball, J
dc.contributor.author Reynolds, CP
dc.contributor.author Seeger, RC
dc.contributor.author Voss, SD
dc.contributor.author Hank, JA
dc.contributor.author Gillies, SD
dc.contributor.author London, WB
dc.contributor.author Shusterman, S
dc.contributor.author Sondel, PM
dc.date.accessioned 2011-09-02T20:42:16Z
dc.date.available 2011-09-02T20:42:16Z
dc.date.issued 2010-11-20
dc.identifier.citation 1: Shusterman S, London WB, Gillies SD, Hank JA, Voss SD, Seeger RC, Reynolds CP, Kimball J, Albertini MR, Wagner B, Gan J, Eickhoff J, DeSantes KB, Cohn SL, Hecht T, Gadbaw B, Reisfeld RA, Maris JM, Sondel PM. Antitumor activity of hu14.18-IL2 in patients with relapsed/refractory neuroblastoma: a Children's Oncology Group (COG) phase II study. J Clin Oncol. 2010 Nov 20;28(33):4969-75. Epub 2010 Oct 4. PubMed PMID: 20921469; PubMed Central PMCID: PMC3020698. en
dc.identifier.uri http://digital.library.wisc.edu/1793/54209
dc.description PMID: 20921469 en
dc.description.abstract PURPOSE: The hu14.18-IL2 fusion protein consists of interleukin-2 molecularly linked to a humanized monoclonal antibody that recognizes the GD2 disialoganglioside expressed on neuroblastoma cells. This phase II study assessed the antitumor activity of hu14.18-IL2 in two strata of patients with recurrent or refractory neuroblastoma. PATIENTS AND METHODS: Hu14.18-IL2 was given intravenously (12 mg/m(2)/daily) for 3 days every 4 weeks for patients with disease measurable by standard radiographic criteria (stratum 1) and for patients with disease evaluable only by [(123)I]metaiodobenzylguanidine (MIBG) scintigraphy and/or bone marrow (BM) histology (stratum 2). Response was established by independent radiology review as well as BM histology and immunocytology, and durability was assessed by repeat evaluation after more than 3 weeks. RESULTS: Thirty-nine patients were enrolled (36 evaluable). No responses were seen in stratum 1 (n = 13). Of 23 evaluable patients in stratum 2, five patients (21.7%) responded; all had a complete response (CR) of 9, 13, 20, 30, and 35+ months duration. Grade 3 and 4 nonhematologic toxicities included capillary leak, hypoxia, pain, rash, allergic reaction, elevated transaminases, and hyperbilirubinemia. Two patients required dopamine for hypotension, and one patient required ventilatory support for hypoxia. Most toxicities were reversible within a few days of completing a treatment course and were expected based on phase I results. CONCLUSION: Patients with disease evaluable only by MIBG and/or BM histology had a 21.7% CR rate to hu14.8-IL2, whereas patients with bulky disease did not respond. Hu14.18-IL2 warrants further testing in children with nonbulky high-risk neuroblastoma. en
dc.description.provenance Submitted by Julie Schneider (jschneider@library.wisc.edu) on 2011-09-02T20:42:16Z No. of bitstreams: 1 Sondel_J_Clin_Oncology_2010.pdf: 524273 bytes, checksum: b4c9265567eb3953f982ea7399403477 (MD5) en
dc.description.provenance Made available in DSpace on 2011-09-02T20:42:16Z (GMT). No. of bitstreams: 1 Sondel_J_Clin_Oncology_2010.pdf: 524273 bytes, checksum: b4c9265567eb3953f982ea7399403477 (MD5) Previous issue date: 2010-11-20 en
dc.title Antitumor activity of hu14.18-IL2 in patients with relapsed/refractory neuroblastoma: a Children's Oncology Group (COG) phase II study en
dc.type Article en

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