Phase I study of recombinant human interleukin-1β(rhIL-1β) in patients with bone marrow failure

J. Nemunaitis, M. Ross, B. Meisenberg, R. O'Reilly, K. Lilleby, C. D. Buckner, F. R. Appelbaum, W. Buhles, J. Singer, W. P. Peters

Research output: Contribution to journalArticlepeer-review

Abstract

The administration of recombinant human interleukin-1β (rhIL-1β) stimulates pluripotent cell growth and reduces mortality from infection in animal models. In this phase I trial, rhIL-1β (0.02-0.50 μg/kg) was administered by 30-minute intravenous infusion once daily for 2 or 5 consecutive days. The dose was escalated with the subsequent cycle in the same patient if no hematologic response was observed. Nineteen patients with severe bone marrow failure received 60 courses of IL-1β. Diagnoses included autologous bone marrow transplant (BMT) (n = 5), allogeneic BMT (n = 7) or idiopathic aplastic anemia (n = 6) and 1 patient with chronic myeloid leukemia. Toxicities included fever (89%), chills (85%), hypertension (89%), hypotension (57%) and headache (95%). No complications were life-threatening and all either spontaneously resolved or were managed pharmacologically. In 8 of 19 patients there was an acute, transient increase in neutrophil counts. In 2 patients there was a transient increase in platelet count; however, no durable, clinically significant effects on peripheral blood counts were observed. In conclusion, administration of rhIL-1β in this population of patients had limited efficacy and moderate toxicity.

Original languageEnglish (US)
Pages (from-to)583-588
Number of pages6
JournalBone marrow transplantation
Volume14
Issue number4
StatePublished - Jan 1 1994

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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