Cairo, M.S., Davenport, V., Bessmertny, O., Goldman, S.C., Berg, S.L., Kreissman, S.G., . . . Reaman, G.H. (2005). Phase I/II dose escalation study of recombinant human interleukin‐11 following ifosfamide, carboplatin and etoposide in children, adolescents and young adults with solid tumours or lymphoma: A clinical, haematological and biological study. British Journal of Haematology, 128, 49–58.
Three of 47 patients withdrew. Also, 24 of 44 discontinued before receiving two cycles (9 because of disease progression; 3 for adverse events [papilloedema]; 2 for therapy changes; 10 for other reasons; 1 died). Twenty patients completed two cycles of therapy. Median time to platelet recovery was reduced (24.5–20 days in similar historical cohort). One patient developed incidence of anti-IL-11 antibody formation. Number of platelet transfusions was three versus six in historical controls. IL-11 was well-tolerated at doses less than 50; the maximum tolerated dose is 50 mcg/kg/day. Doses above this increased side effects of papilloedema in 6 of 26 patients, periosteal bone changes in 4 of 26 patients, and cardiomegaly.