PT  - JOURNAL ARTICLE
AU  - Edmonson, John H.
AU  - Kovach, John S.
AU  - Buckner, Jan C.
AU  - Kvols, Larry K.
AU  - Hahn, Richard G.
TI  - Phase I Study of Difluoromethylornithine in Combination with Recombinant α2a-Interferon
DP  - 1988 Nov 15
TA  - Cancer Research
PG  - 6584--6586
VI  - 48
IP  - 22
4099  - http://cancerres.aacrjournals.org/content/48/22/6584.short
4100  - http://cancerres.aacrjournals.org/content/48/22/6584.full
SO  - Cancer Res1988 Nov 15; 48
AB  - 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 × 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 × 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 × 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. ©1988 American Association for Cancer Research.