NEWS HIGHLIGHTS
Published Studies Related to Kepivance (Palifermin)
Gut protection by palifermin during autologous haematopoietic SCT. [2009.05]
Conditioning therapy in connection with haematopoietic SCT (HSCT) induces a disruption of the intestinal barrier function facilitating the permeation of bacteria and endotoxin through the bowel wall with subsequent increased risk of septicaemia and a worsening of GVHD in the allogeneic setting.
Long-term follow-up of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT). [2008.09]
We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000 to 2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 microg/kg to 720 microg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients... We conclude that the benefits of palifermin appear primarily to be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients.
Phase II study of palifermin and concurrent chemoradiation in head and neck squamous cell carcinoma. [2008.05.20]
PURPOSE: Acute mucositis is a dose-limiting toxicity of concurrent chemoradiotherapy regimens for locally advanced head and neck cancer. Palifermin (a recombinant human keratinocyte growth factor; DeltaN23-KGF) stimulates the proliferation and differentiation of mucosal epithelium to reduce mucositis in patients receiving intensive therapy for hematologic cancers. This study assessed the efficacy and safety of palifermin in patients receiving concurrent chemoradiotherapy for advanced head and neck squamous cell carcinoma... CONCLUSION: Ten once-weekly doses of palifermin at 60 microg/kg were well tolerated. Most patients completed treatment, but palifermin did not reduce the morbidity of concurrent chemotherapy and radiotherapy. Future studies should evaluate higher palifermin doses with longer and more standardized assessment of acute mucositis.
Palifermin: role in the prevention of chemotherapy- and radiation-induced mucositis. [2007.01]
CONCLUSIONS: Treatment with palifermin appears to decrease the severity and duration of severe mucositis following autologous stem cell transplant. Use in these patients appears justified; however, use in non-stem cell transplant patients should be discouraged until more efficacy and toxicity data are available.
Palifermin-associated papular eruption. [2009.02]
CONCLUSIONS: After treatment with palifermin, a papular eruption clinically resembling lichen planus or plane warts, with histologic features of verruca plana, and intertriginous erythema may occur. In this case, neither eruption required treatment, and spontaneous resolution was observed over days to weeks. Histopathologic staining patterns of Ki-67 and cytokeratin 5/6 may be useful in identifying adverse reactions to palifermin therapy.
Clinical Trials Related to Kepivance (Palifermin)
Palifermin After Haploidentical PBSCT [Not yet recruiting]
This is a double blind, placebo controlled clinical trial, where patients with an advanced
form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor
cell (PBPC) transplant after which they are randomised to receive either placebo or a
keratinocyte growth factor (Palifermin or Kepivance®).
The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has
also been suggested to have an ability to help improve the reconstitution, or development,
of the immune system after the transplantation.
The hypothesis is that the patients T-cell dependent humoral immune response to recall
antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo
control group
A Phase 1 Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT [Recruiting]
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias
receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body
irradiation [TBI]) followed by hematopoietic stem cell transplant (HSCT). The study will
evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses
(40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are be evaluated in each age group (1 to 2, 3
to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.
Palifermin is administered for 3 consecutive days (Day - 10 to Day -8, respectively) before
the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following
HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well
tolerated, efficacious dose in each age group. Patients will also be followed for secondary
malignancies, progression-free survival (PFS) and overall survival (OS) for a maximum of 10
years
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [Recruiting]
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
Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) [Recruiting]
The purpose of this study is to find out how good the addition of Palifermin to the
conditioning regimen for a T cell depleted allogeneic stem cell transplant is at lowering
the fatal infectious complications associated with the transplant. The conditioning regimen
is the treatment given before transplantation and will include busulfan, melphalan,
fludarabine, and anti-thymocyte globulin (ATG). An earlier study at this institution showed
that the same conditioning regimen without Palifermin and the same type of transplant was
safe and able to cure patients with MDS/AML. However, the success rate was lowered by fatal
infectious complications happening after the transplant. The new part of this study is the
addition of Palifermin before and after administration of the pre-transplant treatments to
lower these complications. The purpose of this study is also to find out the possible bad
side effects of this new regimen.
Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or
mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for
multiple myeloma.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when
given together with palifermin in treating patients undergoing an autologous peripheral stem
cell transplant for stage II or stage III multiple myeloma.
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