Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Phase I Study Of The Use Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem
cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition
and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human
keratinocyte growth factor that is produced by recombinant DNA technology in E. coli.
Palifermin is a FDA-approved, commercially available pharmacologic agent that is
manufactured by Amgen. As keratinocyte growth factor receptors have been found within the
epithelium of gastric mucosa, the use of palifermin has been proven to decrease the
frequency and duration of severe mucositis in adult studies. Whereas the appropriate dosing
regimen has been determined for adults at 60mcg/kg/day, the dosing of palifermin has not
been established in the pediatric setting. This initial pediatric study of palifermin will
determine the maximum tolerated dose, evaluating the use of this agent at three dose levels,
below, at, and above the recommended adult dose. Non-hematologic, life-threatening NCI grade
IV or grade V toxicities definitely related to the administration of palifermin from the
first infusion until day +6 after HSCT (post palifermin administration day +3) will comprise
the safety endpoints of the study.
The study is designed to evaluate palifermin at 3 dose levels. The study population will be
recipients of either a matched family member donor or matched unrelated donor HSCT. The
pharmacokinetics of palifermin at each dose level will be described to help determine the
appropriate dose for future studies, which will evaluate efficacy
Secondary objectives of this study include exploring the pharmacoeconomics of palifermin in this particular patient population through an assessment of inpatient days, intravenous nutrition, and analgesia requirements within 100 days post-transplantation. We will also explore the research participants' rates of immune reconstitution, specifically T and B-lymphocytes and NK cells, within the first year of HSCT. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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