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Phase I study of recombinant interleukin-1 beta in patients undergoing
autologous bone marrow transplant for acute myelogenous leukemia
J Nemunaitis, FR Appelbaum, K Lilleby, WC Buhles, C Rosenfeld, ZR Zeigler, RK Shadduck, JW Singer, W Meyer and CD Buckner
Fred Hutchinson Cancer Research Center, Seattle, WA.
A phase I trial was conducted with recombinant human interleukin-1 beta
(rhIL-1 beta) in patients undergoing autologous bone marrow (BM)
transplantation for acute myelogenous leukemia. rhIL-1 beta was
administered at 3 dose levels (0.01, 0.02, 0.05 microgram/kg) by 30 minute
intravenous infusion once a day beginning on the day of BM infusion and
continuing for a total of 5 doses. A total of 17 patients were entered on
the trial, and their results were compared with those of 74 consecutive
historical control patients that did not receive colony stimulating
factors. Moderate toxicity was observed in all patients. All 17 patients
developed fever and chills within 30 minutes after initiation of rhIL-1
beta, and hypotension was observed in 14 of 17 patients 5 to 8 hours after
the infusion. A total of 30% of patients required therapy (normal saline or
dopamine) for treatment of hypotension. Therefore, dose escalation was
discontinued at the 0.05 microgram/kg dose level. The number of days
required to achieve an absolute neutrophil count greater than 500 mL in
patients who received rhIL-1 beta was less than in historical patients (25
v 34; P = .02). This appeared to correlate with a reduced incidence of
infection between days 0 and 28 after BM infusion (12% v 23%; P = .049).
Median bilirubin, median creatinine, platelet recovery, and days in the
hospital were not different between study patients and historical controls.
Survival of patients who received rhIL-1 beta compared with that of
historical patients was improved (30% v 20%; P = .04). These possible
benefits were achieved at the cost of moderate toxicity during rhIL-1 beta
administration.
Volume 83,
Issue 12,
pp. 3473-3479,
06/15/1994
Copyright © 1994 by The American Society of Hematology
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