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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.

Publication ,  Journal Article
Crown, J; Jakubowski, A; Kemeny, N; Gordon, M; Gasparetto, C; Wong, G; Sheridan, C; Toner, G; Meisenberg, B; Botet, J
Published in: Blood
September 15, 1991

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.

Duke Scholars

Published In

Blood

ISSN

0006-4971

Publication Date

September 15, 1991

Volume

78

Issue

6

Start / End Page

1420 / 1427

Location

United States

Related Subject Headings

  • Rectal Neoplasms
  • Recombinant Proteins
  • Platelet Count
  • Neutropenia
  • Neoplasms, Unknown Primary
  • Middle Aged
  • Male
  • Leukocyte Count
  • Interleukin-1
  • Immunology
 

Citation

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Crown, J., Jakubowski, A., Kemeny, N., Gordon, M., Gasparetto, C., Wong, G., … Botet, J. (1991). 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. Blood, 78(6), 1420–1427.
Crown, J., A. Jakubowski, N. Kemeny, M. Gordon, C. Gasparetto, G. Wong, C. Sheridan, G. Toner, B. Meisenberg, and J. Botet. “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.Blood 78, no. 6 (September 15, 1991): 1420–27.
Crown J, Jakubowski A, Kemeny N, Gordon M, Gasparetto C, Wong G, Sheridan C, Toner G, Meisenberg B, Botet J. 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. Blood. 1991 Sep 15;78(6):1420–1427.

Published In

Blood

ISSN

0006-4971

Publication Date

September 15, 1991

Volume

78

Issue

6

Start / End Page

1420 / 1427

Location

United States

Related Subject Headings

  • Rectal Neoplasms
  • Recombinant Proteins
  • Platelet Count
  • Neutropenia
  • Neoplasms, Unknown Primary
  • Middle Aged
  • Male
  • Leukocyte Count
  • Interleukin-1
  • Immunology