Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00701688
Study type Interventional
Source St. Jude Children's Research Hospital
Contact
Status Completed
Phase Phase 1
Start date September 2007
Completion date February 2012

See also
  Status Clinical Trial Phase
Completed NCT00766883 - Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant Phase 2
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Completed NCT02564458 - Fitness in Allogeneic Stem Cell Transplantation N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT04092309 - Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation N/A
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Recruiting NCT04937634 - Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT04203108 - ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis Phase 4
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Withdrawn NCT03279133 - Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. Phase 4
Completed NCT05151406 - Myths and Misconceptions About HSCT in a Limited Resource Region N/A
Completed NCT02241005 - Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci N/A
Recruiting NCT03689465 - PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis Phase 4
Recruiting NCT04868786 - Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT03010579 - Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation Phase 4
Active, not recruiting NCT00959140 - Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors N/A