Antitumor Activity of Hu14.18-IL2 in Patients With Relapsed/Refractory Neuroblastoma: A Children's Oncology Group (COG) Phase II Study
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 r...
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| Published in | Journal of clinical oncology Vol. 28; no. 33; pp. 4969 - 4975 |
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| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Alexandria, VA
American Society of Clinical Oncology
20.11.2010
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0732-183X 1527-7755 1527-7755 |
| DOI | 10.1200/JCO.2009.27.8861 |
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| Abstract | 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.
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.
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.
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. |
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| AbstractList | 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/m2/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 [123I]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. 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. 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. 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. 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. 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.PURPOSEThe 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.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.PATIENTS AND METHODSHu14.18-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.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.RESULTSThirty-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.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.CONCLUSIONPatients 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. |
| Author | Brian Gadbaw Jennifer Kimball Mark R. Albertini Jacek Gan Wendy B. London Susan L. Cohn Toby Hecht Stephan D. Voss Ralph A. Reisfeld Paul M. Sondel John M. Maris Suzanne Shusterman Barrett Wagner Jens Eickhoff Jacquelyn A. Hank Stephen D. Gillies C. Patrick Reynolds Kenneth B. DeSantes Robert C. Seeger |
| Author_xml | – sequence: 1 givenname: Suzanne surname: Shusterman fullname: Shusterman, Suzanne organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 2 givenname: Wendy B. surname: London fullname: London, Wendy B. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 3 givenname: Stephen D. surname: Gillies fullname: Gillies, Stephen D. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 4 givenname: Jacquelyn A. surname: Hank fullname: Hank, Jacquelyn A. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 5 givenname: Stephan D. surname: Voss fullname: Voss, Stephan D. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 6 givenname: Robert C. surname: Seeger fullname: Seeger, Robert C. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 7 givenname: C. Patrick surname: Reynolds fullname: Reynolds, C. Patrick organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 8 givenname: Jennifer surname: Kimball fullname: Kimball, Jennifer organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 9 givenname: Mark R. surname: Albertini fullname: Albertini, Mark R. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 10 givenname: Barrett surname: Wagner fullname: Wagner, Barrett organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 11 givenname: Jacek surname: Gan fullname: Gan, Jacek organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 12 givenname: Jens surname: Eickhoff fullname: Eickhoff, Jens organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 13 givenname: Kenneth B. surname: DeSantes fullname: DeSantes, Kenneth B. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 14 givenname: Susan L. surname: Cohn fullname: Cohn, Susan L. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 15 givenname: Toby surname: Hecht fullname: Hecht, Toby organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 16 givenname: Brian surname: Gadbaw fullname: Gadbaw, Brian organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 17 givenname: Ralph A. surname: Reisfeld fullname: Reisfeld, Ralph A. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 18 givenname: John M. surname: Maris fullname: Maris, John M. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's – sequence: 19 givenname: Paul M. surname: Sondel fullname: Sondel, Paul M. organization: From the Dana-Farber Cancer Institute and Children's Hospital Boston, Boston; Children's Oncology Group Statistics and Data Center, Gainesville, FL; Provenance Biopharmaceuticals, Waltham, MA; University of Wisconsin Carbone Cancer Center, Madison WI; Children's Hospital of Los Angeles, Los Angeles; The Scripps Research Institute, La Jolla, CA; University of Texas, Lubbock, TX; University of Chicago, Chicago, IL; National Cancer Institute, Biologic Resources Branch, Frederick, MD; and The Children's |
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| Snippet | The hu14.18-IL2 fusion protein consists of interleukin-2 molecularly linked to a humanized monoclonal antibody that recognizes the GD2 disialoganglioside... PURPOSE: The hu14.18-IL2 fusion protein consists of interleukin-2 molecularly linked to a humanized monoclonal antibody that recognizes the GD2... |
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| SubjectTerms | Adolescent Adult Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - blood Antibodies, Monoclonal - immunology Antibodies, Monoclonal - therapeutic use Antineoplastic Agents - therapeutic use Biological and medical sciences Child Child, Preschool Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage Humans Infant Interleukin-2 - adverse effects Interleukin-2 - blood Interleukin-2 - immunology Interleukin-2 - therapeutic use Lymphocyte Count Medical sciences Neuroblastoma - drug therapy Neuroblastoma - mortality Neurology Original Reports Receptors, Interleukin-2 - blood Tumors Tumors of the nervous system. Phacomatoses |
| Title | 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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