ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2008
Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant.
Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 4 of them syntheses that pooled it.
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Who cites it
9 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Systematic review of growth factors and cytokines for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Pooled it
- Autologous hematopoietic stem cell transplantation following high dose chemotherapy for non-rhabdomyosarcoma soft tissue sarcomas.The Cochrane database of systematic reviews · 2013Pooled it
- Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013Pooled it
- Interventions for preventing oral mucositis for patients with cancer receiving treatment.The Cochrane database of systematic reviews · 2011Pooled it
- Radioprotection of normal tissue cells.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2014Review
- Melphalan 180 mg/m2 can be safely administered as conditioning regimen before an autologous stem cell transplantation (ASCT) in multiple myeloma patients with creatinine clearance 60 mL/min/1.73 m2 or lower with use of palifermin for cytoprotection: results of a phase I trial.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2012Article
- The FGF family: biology, pathophysiology and therapy.Nature reviews. Drug discovery · 2009Review
- Palifermin for management of treatment-induced oral mucositis in cancer patients.Biologics : targets & therapy · 2009Article
- Dentofacial parameters explaining variability in retroclination of the maxillary central incisors.Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie · 2007Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
goals of workThe objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe oral mucositis (OM) from chemotherapy. MATERIALS AND
methodsThis study was a single-center, open-label, single-dose escalation, phase I trial in patients undergoing high-dose chemotherapy (HDCT) and autologous peripheral blood stem cell transplant (PBSCT). Velafermin was administered 24 h after stem cell infusion as a single intravenous dose infused over 15 min. Clinical safety variables were assessed and OM status scored daily for 30 days using the World Health Organization (WHO) grading scale. MAIN
resultsThirty patients were treated with velafermin at doses of 0.03 (n = 10), 0.1 (n = 10), 0.2 (n = 8), or 0.33 mg/kg (n = 2). Patients were diagnosed with multiple myeloma (n = 16), non-Hodgkin's lymphoma (n = 12), acute myelogenous leukemia (n = 1), or desmoplasmic round cell tumor (n = 1). Velafermin was well tolerated at doses up to 0.2 mg/kg. There were no drug-related serious adverse events. No patient discontinued because of adverse events; however, two patients administered 0.33 mg/kg developed adverse reactions immediately after infusion of the study drug. No other patients were treated at this dose level. The most frequent (>35% of patients) treatment-emergent adverse events were diarrhea, fatigue, pyrexia, vomiting, and nausea. Most adverse events were mild or moderate and resolved the same day without sequelae. Eight (27%) patients developed WHO grade 3 or 4 OM during the study; seven of these patients received high-dose melphalan as a conditioning regimen.
conclusionVelafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg.
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