Phase I study of difluoromethylornithine in combination with recombinant α2a-interferon

J. H. Edmonson, J. S. Kovach, Jan Craig Buckner, L. K. Kvols, R. G. Hahn

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

24 patients with advanced, histologically proven cancer were treated with difluoromethylornithine 2.25 g/m2 orally every 6 h for the first 7 days of each 4-week treatment cycle. These patients also received daily i.m. doses of recombinant human α2a-interferon (IFN) on Days 3 through 7 of each cycle. IFN doses of 3, 6, 12, 24, 36, and 48 x 106 units/m2 have been studied utilizing three patients at each daily dose level. Three additional patients have been observed at each of the two highest doses for better toxicity definition. This combination produced slight transient declines in leukocyte and platelet counts and transient rises in serum aspartate aminotransferase; however, these changes were no more pronounced at the higher IFN doses than at daily doses of 6 x 106 units/m2. Mild nausea and vomiting occurred in most patients and mild diarrhea also was common at all IFN dose levels. Chills, fever, myalgia, lethargy and fatigue, and anorexia were also observed at all IFN doses; however, lethargy and fatigue (lassitude) seemed to be the major factor which limited patient tolerance of IFN to 48 x 106 units/m2 daily. No ototoxicity was identified clinically or audiometrically and no life-threatening toxicity has occurred. Initial Phase II studies in melanoma are currently in progress.

Original languageEnglish (US)
Pages (from-to)6584-6586
Number of pages3
JournalCancer Research
Volume48
Issue number22
StatePublished - 1988

Fingerprint

Eflornithine
Interferons
Fatigue
Lethargy
Chills
Myalgia
Anorexia
Aspartate Aminotransferases
Platelet Count
Leukocyte Count
Nausea
Vomiting
Diarrhea
Melanoma
Fever
Serum
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Edmonson, J. H., Kovach, J. S., Buckner, J. C., Kvols, L. K., & Hahn, R. G. (1988). Phase I study of difluoromethylornithine in combination with recombinant α2a-interferon. Cancer Research, 48(22), 6584-6586.

Phase I study of difluoromethylornithine in combination with recombinant α2a-interferon. / Edmonson, J. H.; Kovach, J. S.; Buckner, Jan Craig; Kvols, L. K.; Hahn, R. G.

In: Cancer Research, Vol. 48, No. 22, 1988, p. 6584-6586.

Research output: Contribution to journalArticle

Edmonson, JH, Kovach, JS, Buckner, JC, Kvols, LK & Hahn, RG 1988, 'Phase I study of difluoromethylornithine in combination with recombinant α2a-interferon', Cancer Research, vol. 48, no. 22, pp. 6584-6586.
Edmonson, J. H. ; Kovach, J. S. ; Buckner, Jan Craig ; Kvols, L. K. ; Hahn, R. G. / Phase I study of difluoromethylornithine in combination with recombinant α2a-interferon. In: Cancer Research. 1988 ; Vol. 48, No. 22. pp. 6584-6586.
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