Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant

Schuster, Michael W.; Shore, Tsiporah B.; Harpel, John G.; Greenberg, June; Jalilizeinali, Bita; Possley, Scott; Gerwien, Robert; Hahne, William F.; Halvorsen, Yuan-Di C.

doi:10.1007/s00520-007-0325-9

Cited by 16 publications

(6 citation statements)

References 16 publications

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“…Studies performed on FGF-20 (velafermin) [8] and KGF-2 (repifermin) [9] did not allow a guideline due to insufficient evidence. The study on velafermin was a single center, phase I, open label, dose escalation study assessing the safety and tolerability of this growth factor.…”

Section: Resultsmentioning

confidence: 99%

“…Animal studies suggest that KGF-1 decreases graft-versus-host disease (GVHD) associated with allogeneic hematopoietic stem cell transplantation (HSCT) [5,6] and enhances T cell reconstitution [7]. Two other members of the KGF family, FGF-20 (velafermin) [8] and human recombinant KGF-2 (repifermin) [9], have overlapping activity with KGF-1 but may also have other actions that impact their effectiveness.…”

Section: Introductionmentioning

confidence: 99%

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Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Raber-Durlacher

Bültzingslöwen²,

Logan

et al. 2012

Support Care Cancer

113

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Purpose The aim of this project was to review the literature and define clinical practice guidelines for the use of cytokines and growth factor agents for the prevention or treatment of oral mucositis induced by cancer chemotherapy or radiotherapy. Care Cancer (2013) 21:343-355 DOI 10.1007/s00520-012-1594 following three guideline determinations was possible: Recommendation, Suggestion, No guideline possible. Results Sixty-four clinical studies across 11 interventions were evaluated. A recommendation was made for the use of recombinant human KGF-1 (palifermin) at a dose of 60 μg/kg per day for 3 days prior to conditioning treatment and for 3 days post-transplant for prevention of oral mucositis in patients receiving high-dose chemotherapy and total body irradiation followed by autologous stem cell transplantation for hematological malignancies. A suggestion was made against using granulocyte macrophage colony-stimulating factor mouthwash for the prevention of oral mucositis in the setting of high-dose chemotherapy followed by autologous or allogeneic stem cell transplantation. No guideline was possible for any other cytokine or growth factor agents due to inconclusive evidence. Conclusions Of the cytokine and growth factor agents studied for oral mucositis, the evidence only supports use of palifermin in the specific population listed above. Additional welldesigned research is needed on other cytokine and growth factor interventions and in other cancer treatment settings. Methods

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Raber-Durlacher

Bültzingslöwen²,

Logan

et al. 2012

Support Care Cancer

113

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“…Although Phase I clinical trials were promising 177 , the project was terminated in October 2007 when Phase II trials failed to meet therapeutic targets.…”

Section: Fgf9 Subfamilymentioning

confidence: 99%

The FGF family: biology, pathophysiology and therapy

Beenken

Mohammadi

2009

Nat Rev Drug Discov

1,649

1,460

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The family of fibroblast growth factors (FGFs) regulates a plethora of developmental processes, including brain patterning, branching morphogenesis and limb development. Several mitogenic, cytoprotective and angiogenic therapeutic applications of FGFs are already being explored, and the recent discovery of the crucial roles of the endocrine-acting FGF19 subfamily in bile acid, glucose and phosphate homeostasis has sparked renewed interest in the pharmacological potential of this family. This Review discusses traditional applications of recombinant FGFs and small-molecule FGF receptor kinase inhibitors in the treatment of cancer and cardiovascular disease and their emerging potential in the treatment of metabolic syndrome and hypophosphataemic diseases.

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“…Currently, palliation and treatment of OM is achieved through topical and systemic analgesia [14]. Novel agents such as velafermin (no longer available) and amifostine have been evaluated with mixed results [15–17]. They have not been shown to improve outcomes, and thus there are no consensus recommendations for their use.…”

Section: Introductionmentioning

confidence: 99%

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

Abidi

Agarwal

Ayash

et al. 2012

Biology of Blood and Marrow Transplantation

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High-dose melphalan 140 mg/m2 is the standard of care for patients with multiple myeloma (MM) with renal insufficiency (RI). Palifermin as a cytoprotective agent has demonstrated efficacy in reducing the intensity and duration of oral mucositis (OM) in patients who receive intensive chemotherapy/radiotherapy. There is no prospective data on the use of palifermin in patients with MM with RI. Eligibility criteria: creatinine clearance ≤60 mL/minute/1.73 m2, age >18 years, no dialysis, no active OM, and a suitable candidate for autologous stem cell transplant (ASCT). Melphalan dose ranged from 140 to 200 mg/m2 and escalated at the increment of 20 mg/m2. Six dosages of palifermin 60 mcg/kg/day were given intravenously between day −5 to day +3. Dose escalations were to stop if dose-limiting toxicities (DLTs) occurred at melphalan dose in ≥2 of 3 patients, with that dose declared as the maximal administered dose and the level below where ≤1 of 6 patients had DLTs was considered the maximally tolerated dose (MTD). Nineteen patients were enrolled from June 2007 to June 2011. Data on 15 evaluable patients is reported as 4 patients were removed. Median age was 59 years (range, 36–67 years). The overall incidence of OM ≥ grade 3 was 53% (8 of 15) and a median duration of ≥ grade 3 OM was 6.5 days (range, 3–42 days). One patient in L2 (melphalan 160 mg/m2) developed atrial fibrillation on day +9. Two patients in L4 (melphalan 200 mg/m2) developed grade 4 OM, hence reaching DLT. No DLT was observed in 6 patients enrolled in L3 (melphalan 180 mg/m2). Palifermin has permitted safe dose escalation of melphalan up to 180 mg/m2 in patients with RI.

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Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant

Abstract: Velafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg.

Cited by 16 publications

References 16 publications

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

The FGF family: biology, pathophysiology and therapy

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

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