A phase I trial: Dose escalation of melphalan in the "BEAM" regimen using amifostine cytoprotection

Gordon L. Phillips, Steven H. Bernstein, Jane L. Liesveld, Camille N. Abboud, Michael W. Becker, Louis S. Constine, J. J. Ifthikharuddin, John E. Loughner, Laurie A. Milner, David H. Vesole, Jonathan W. Friedberg

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Abstract

With the eventual goal of reducing relapse and thus improving overall survival in selected lymphoma patients, a Phase I study was performed using the cytoprotectant amifostine to permit safe dose-augmentation of melphalan in the carmustine (BCNU), etoposide, cytarabine (arabinosylcytosine), and melphalan (BEAM) regimen before autologous hematopoietic stem cell transplantation. Between 30 July 2003 and 25 November 2008, a total of 32 lymphoma patients were entered, of which 28 were evaluable. We found the melphalan dose in BEAM could be safely escalated to at least 260 mg/m2, a substantial increase from the usual dose of 140 mg/m2 in BEAM while the trial was terminated early due to poor accrual, no maximal tolerated dose or dose-limiting toxicity was found. A Phase II trial is planned.

Original languageEnglish
Pages (from-to)1033-1042
Number of pages10
JournalBiology of Blood and Marrow Transplantation
Volume17
Issue number7
DOIs
StatePublished - Jul 1 2011

Keywords

  • Amifostine
  • Autologous stem cell
  • Melphalan
  • Phase I
  • Regimen-related toxicity

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    Phillips, G. L., Bernstein, S. H., Liesveld, J. L., Abboud, C. N., Becker, M. W., Constine, L. S., Ifthikharuddin, J. J., Loughner, J. E., Milner, L. A., Vesole, D. H., & Friedberg, J. W. (2011). A phase I trial: Dose escalation of melphalan in the "BEAM" regimen using amifostine cytoprotection. Biology of Blood and Marrow Transplantation, 17(7), 1033-1042. https://doi.org/10.1016/j.bbmt.2010.11.003