title: A Phase I trial: dose escalation of melphalan in the "BEAM" regimen using amifostine cytoprotection.
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.
authors.affiliation: Hematology Oncology, University of Rochester Medical Center, James P. Wilmot Cancer Center, Strong Memorial Hospital, Rochester, New York 14642, USA. louise_haskins@umc.rochester.edu
authors.forename: Gordon L
authors.initials: GL
authors.lastname: Phillips
authors.forename: Steven H
authors.initials: SH
authors.lastname: Bernstein
authors.forename: Jane L
authors.initials: JL
authors.lastname: Liesveld
authors.forename: Camille N
authors.initials: CN
authors.lastname: Abboud
authors.forename: Michael W
authors.initials: MW
authors.lastname: Becker
authors.forename: Louis S
authors.initials: LS
authors.lastname: Constine
authors.forename: J J
authors.initials: JJ
authors.lastname: Ifthikharuddin
authors.forename: John E
authors.initials: JE
authors.lastname: Loughner
authors.forename: Laurie A
authors.initials: LA
authors.lastname: Milner
authors.forename: David H
authors.initials: DH
authors.lastname: Vesole
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000139:chemically induced; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D019610:Cytoprotection / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery; D008297:Male; D020714:Maximum Tolerated Dose; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D010198:Pancytopenia / Q000139:chemically induced; D036102:Peripheral Blood Stem Cell Transplantation; D011183:Postoperative Complications / Q000139:chemically induced; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D003561:Cytarabine; D005047:Etoposide; D004999:Amifostine; D008558:Melphalan; D002330:Carmustine