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A phase I trial of recombinant human interleukin-1 beta alone and in
combination with myelosuppressive doses of 5-fluorouracil in patients with
gastrointestinal cancer
J Crown, A Jakubowski, N Kemeny, M Gordon, C Gasparetto, G Wong, C Sheridan, G Toner, B Meisenberg and J Botet
Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
We studied escalating doses of recombinant human interleukin-1 beta (IL- 1
beta) alone and after a myelosuppressive dose of 5-fluorouracil (5- FU) in
patients with gastrointestinal cancer. Transient neutropenia,
monocytopenia, and lymphocytopenia were observed followed by a 1.3- to
6.0-fold (mean, 3.46-fold) dose-dependent neutrophil leukocytosis (P less
than .00001) on the days of IL-1 beta administration. Increases in platelet
counts were observed at a median of 14 days (range, 6 to 23) after IL-1
beta administration. Transient hypoglycemia, rebound hyperglycemia,
elevations in serum cortisol, and C-reactive protein were observed. Side
effects included fever, rigors, and headache in the majority of patients.
Hypotension was observed in three of five patients at the highest dose
level (0.1 micrograms/kg) and was dose- limiting. Fewer days of neutropenia
were noted after 5-FU plus IL-1 beta than after 5-FU alone; however, this
difference did not reach statistical significance. These data show that
IL-1 beta has stimulatory effects in human hematopoiesis.
Volume 78,
Issue 6,
pp. 1420-1427,
09/15/1991
Copyright © 1991 by The American Society of Hematology
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