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Article: Phase I Study of the Tolerability and Pharmacokinetics of Palifermin in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

TitlePhase I Study of the Tolerability and Pharmacokinetics of Palifermin in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Authors
KeywordsKeratinocyte growth factor
Clearance
Toxicity
Issue Date2012
Citation
Biology of Blood and Marrow Transplantation, 2012, v. 18, n. 8, p. 1309-1314 How to Cite?
AbstractThe maximum tolerated dose of palifermin, a keratinocyte growth factor, in children is not known, and its pharmacokinetics in this population has not been well studied. This is a phase I study of palifermin was designed to evaluate its tolerability at doses of 40, 60, and 90 μg/kg/day in children age 2-18 years of age, receiving a myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). In each cohort, palifermin was given for 3 consecutive days before the preparative regimen and for 3 days after the stem cell infusion. Twelve patients were enrolled. Palifermin 90 μg/kg/day was tolerated in 6 patients without dose-limiting toxicity. All patients had at least 1 adverse event, mostly National Cancer Institute grade 1 or 2 severity. Skin rash, grade 2 or lower, was the most common adverse event, seen in 67% of patients. Only 3 patients (25%) had mucositis. The area under the concentration-time curve increased proportionally to the dose, and approximately 97% of palifermin exposure occurred in the first 24 hours after administration. Palifermin clearance increased linearly with body weight, supporting dosing by body weight. The mean clearance was 1893 mL/hour/kg, and it did not change significantly between administration of the first and last doses (P = .80). The mean elimination half-life was 4.6 hours. Our data show that palifermin was tolerated at a dose of 90 μg/kg/day, and exhibits linear pharmacokinetics in children undergoing allogeneic HSCT. © 2012 American Society for Blood and Marrow Transplantation.
Persistent Identifierhttp://hdl.handle.net/10722/294382
ISSN
2020 Impact Factor: 5.742
2015 SCImago Journal Rankings: 2.094
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSrinivasan, Ashok-
dc.contributor.authorKasow, Kimberly A.-
dc.contributor.authorCross, Shane-
dc.contributor.authorParrish, Melissa-
dc.contributor.authorWang, Chong-
dc.contributor.authorSrivastava, Deo K.-
dc.contributor.authorCai, Xiangjun-
dc.contributor.authorPanetta, John C.-
dc.contributor.authorLeung, Wing-
dc.date.accessioned2020-12-03T08:22:36Z-
dc.date.available2020-12-03T08:22:36Z-
dc.date.issued2012-
dc.identifier.citationBiology of Blood and Marrow Transplantation, 2012, v. 18, n. 8, p. 1309-1314-
dc.identifier.issn1083-8791-
dc.identifier.urihttp://hdl.handle.net/10722/294382-
dc.description.abstractThe maximum tolerated dose of palifermin, a keratinocyte growth factor, in children is not known, and its pharmacokinetics in this population has not been well studied. This is a phase I study of palifermin was designed to evaluate its tolerability at doses of 40, 60, and 90 μg/kg/day in children age 2-18 years of age, receiving a myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). In each cohort, palifermin was given for 3 consecutive days before the preparative regimen and for 3 days after the stem cell infusion. Twelve patients were enrolled. Palifermin 90 μg/kg/day was tolerated in 6 patients without dose-limiting toxicity. All patients had at least 1 adverse event, mostly National Cancer Institute grade 1 or 2 severity. Skin rash, grade 2 or lower, was the most common adverse event, seen in 67% of patients. Only 3 patients (25%) had mucositis. The area under the concentration-time curve increased proportionally to the dose, and approximately 97% of palifermin exposure occurred in the first 24 hours after administration. Palifermin clearance increased linearly with body weight, supporting dosing by body weight. The mean clearance was 1893 mL/hour/kg, and it did not change significantly between administration of the first and last doses (P = .80). The mean elimination half-life was 4.6 hours. Our data show that palifermin was tolerated at a dose of 90 μg/kg/day, and exhibits linear pharmacokinetics in children undergoing allogeneic HSCT. © 2012 American Society for Blood and Marrow Transplantation.-
dc.languageeng-
dc.relation.ispartofBiology of Blood and Marrow Transplantation-
dc.subjectKeratinocyte growth factor-
dc.subjectClearance-
dc.subjectToxicity-
dc.titlePhase I Study of the Tolerability and Pharmacokinetics of Palifermin in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation-
dc.typeArticle-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1016/j.bbmt.2012.04.013-
dc.identifier.pmid22542710-
dc.identifier.pmcidPMC3539307-
dc.identifier.scopuseid_2-s2.0-84864005450-
dc.identifier.volume18-
dc.identifier.issue8-
dc.identifier.spage1309-
dc.identifier.epage1314-
dc.identifier.eissn1523-6536-
dc.identifier.isiWOS:000307040800022-
dc.identifier.issnl1083-8791-

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