TY - JOUR
T1 - A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies
T2 - Results of a trial terminated by excessive toxicity
AU - Abbruzzese, James L.
AU - Levin, Bernard
AU - Ajani, Jaffer A.
AU - Faintuch, Jack S.
AU - Pazdur, Richard
AU - Saks, Samuel
AU - Edwards, Charlene
AU - Gutterman, Jordan U.
N1 - Copyright:
Copyright 2015 Elsevier B.V., All rights reserved.
PY - 1990/10
Y1 - 1990/10
N2 - Recombinant human tumor necrosis factor and recombinant human interferon-gamma are two representatives of a novel class of antineoplastic agents. Evaluation of these agents in vitro has suggested that the combination would be more effective than either agent alone. A prior phase I study demonstrated that the maximum tolerated dose for each agent was 150 μg/m2/day for 5 days when administered concomitantly. Based on this experience, a phase II trial of patients with biliary tract, pancreatic, and colorectal cancer was planned. Our goal was to treat a minimum of 14 patients with each tumor type. However, in the first 13 patients entered into this trial the toxic effects at the starting doses of 125 μg/m2/day for 5 days for each agent were intolerable, with four patients unable to complete planned therapy. In this cohort of patients, no objective responses were observed. Further clinical investigation of this combination should consider alternative treatment schedules to reproduce the in vitro synergistic cytotoxicity of this combination while minimizing host toxicity.
AB - Recombinant human tumor necrosis factor and recombinant human interferon-gamma are two representatives of a novel class of antineoplastic agents. Evaluation of these agents in vitro has suggested that the combination would be more effective than either agent alone. A prior phase I study demonstrated that the maximum tolerated dose for each agent was 150 μg/m2/day for 5 days when administered concomitantly. Based on this experience, a phase II trial of patients with biliary tract, pancreatic, and colorectal cancer was planned. Our goal was to treat a minimum of 14 patients with each tumor type. However, in the first 13 patients entered into this trial the toxic effects at the starting doses of 125 μg/m2/day for 5 days for each agent were intolerable, with four patients unable to complete planned therapy. In this cohort of patients, no objective responses were observed. Further clinical investigation of this combination should consider alternative treatment schedules to reproduce the in vitro synergistic cytotoxicity of this combination while minimizing host toxicity.
KW - Combination biological therapy
KW - Gastrointestinal cancer
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M3 - Article
C2 - 2123922
AN - SCOPUS:0025092625
SN - 0732-6580
VL - 9
SP - 522
EP - 527
JO - Journal of Biological Response Modifiers
JF - Journal of Biological Response Modifiers
IS - 5
ER -