A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy

Francis J Giles; Roberto Rodriguez; Daniel Weisdorf; John R Wingard; Paul J Martin; Thomas R Fleming; Stuart L Goldberg; Elias J Anaissie; Brian J Bolwell; Nelson J Chao; Thomas C Shea; Mark M Brunvand; William Vaughan; Finn Petersen; Mark Schubert; Hillard M Lazarus; Richard T Maziarz; Margarida Silverman; Roy A Beveridge; Rebecca Redman; Janis G Pulliam; Patricia Devitt-Risse; Henry J Fuchs; David D Hurd

doi:10.1016/j.leukres.2003.10.021

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A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy

Journal article

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A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy

Francis J Giles, Roberto Rodriguez, Daniel Weisdorf, John R Wingard, Paul J Martin, Thomas R Fleming, Stuart L Goldberg, Elias J Anaissie, Brian J Bolwell, Nelson J Chao, …

Leukemia research, Vol.28(6), pp.559-565

2004

DOI: 10.1016/j.leukres.2003.10.021

PMID: 15120931

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Abstract

The invasion and colonization of oral cavity mucosal tissues by microflora may contribute to the pathophysiology of ulcerative oral mucositis (UOM). Iseganan is an analog of protegrin-1, a naturally occurring peptide with broad-spectrum microbicidal activity. A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of iseganan in preventing UOM after stomatotoxic therapy. Patients received an oral rinse, consisting of iseganan 9 mg or placebo, to be swished/swallowed six times daily, starting with stomatotoxic therapy and continuing up to 21 days. Patients were assessed for stomatitis and UOM, and administered a questionnaire evaluating mouth pain and difficulty swallowing thrice weekly. The primary study efficacy endpoint was the proportion of patients who did not have peak stomatitis NCI-CTC grade ≥2. Between November 2001 and June 2002, 502 patients were randomized to receive iseganan (251) or placebo (251). Equivalent numbers of patients in both cohorts received bone marrow or peripheral blood allogeneic or autologous stem cell transplantation (SCT). Forty-three percent and 37% of iseganan and placebo patients, respectively, did not have peak stomatitis grade =2 ( P=0.182). There was no significant difference between the cohorts in stomatitis severity, incidence of UOM, peak mouth pain, peak difficulty swallowing, amount of opiate analgesics used, or adverse event type or incidence. A major impact of Iseganan on reducing stomatitis, UOM, or its clinical sequelae in patients receiving stomatotoxic therapy was not detected on this study.

Stomatitis

Oral mucositis

Iseganan

Ulcerative

Details

Title: Subtitle: A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy
Creators: Francis J Giles - M.D. Anderson Cancer Center, Department of Leukemia, The University of Texas, 1515 Holcombe Boulevard, Box 428, Houston, TX 77030, USA
Roberto Rodriguez - City of Hope National Medical Center, Duarte, CA, USA
Daniel Weisdorf - University of Minnesota, Minneapolis, MN, USA
John R Wingard - University of Florida College of Medicine, Gainesville, FL, USA
Paul J Martin - Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Thomas R Fleming - University of Washington
Stuart L Goldberg - Hackensack University Medical Center, Hackensack, NJ, USA
Elias J Anaissie - University of Arkansas for Medical Sciences, Little Rock, AR, USA
Brian J Bolwell - Cleveland Clinic Foundation, Cleveland, OH, USA
Nelson J Chao - Duke University, Durham, NC, USA
Thomas C Shea - University of North Carolina, Chapel Hill, NC, USA
Mark M Brunvand - Rocky Mountain Blood and Morrow Transplant Program, Denver, CO, USA
William Vaughan - University of Alabama-Birmingham, Birmingham, AL, USA
Finn Petersen - University of Utah Hospital, Salt Lake City, UT, USA
Mark Schubert - Seattle Cancer Care Alliance, Seattle, WA, USA
Hillard M Lazarus - Ireland Cancer Center, Case Western Reserve University, Cleveland, OH, USA
Richard T Maziarz - Oregon Health and Science University, Portland, OR, USA
Margarida Silverman - University of Iowa Hospitals and Clinics, Iowa City, IA, USA
Roy A Beveridge - Inova Fairfax Hospital, Falls Church, VA, USA
Rebecca Redman - IntraBiotics Pharmaceuticals Inc., Mountain View, CA, USA
Janis G Pulliam - IntraBiotics Pharmaceuticals Inc., Mountain View, CA, USA
Patricia Devitt-Risse - IntraBiotics Pharmaceuticals Inc., Mountain View, CA, USA
Henry J Fuchs - IntraBiotics Pharmaceuticals Inc., Mountain View, CA, USA
David D Hurd - Wake Forest University Health Sciences, Winston-Salem, NC, USA
Resource Type: Journal article
Publication Details: Leukemia research, Vol.28(6), pp.559-565
DOI: 10.1016/j.leukres.2003.10.021
PMID: 15120931
NLM abbreviation: Leuk Res
ISSN: 0145-2126
eISSN: 1873-5835
Publisher: Elsevier Ltd
Language: English
Date published: 2004
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094658202771

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