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A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity.

Publication ,  Journal Article
Abbruzzese, JL; Levin, B; Ajani, JA; Faintuch, JS; Pazdur, R; Saks, S; Edwards, C; Gutterman, JU
Published in: J Biol Response Mod
October 1990

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 micrograms/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 micrograms/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.

Duke Scholars

Published In

J Biol Response Mod

ISSN

0732-6580

Publication Date

October 1990

Volume

9

Issue

5

Start / End Page

522 / 527

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Severity of Illness Index
  • Recombinant Proteins
  • Middle Aged
  • Male
  • Interferon-gamma
  • Humans
  • Gastrointestinal Neoplasms
  • Female
  • Drug Evaluation
 

Citation

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Abbruzzese, J. L., Levin, B., Ajani, J. A., Faintuch, J. S., Pazdur, R., Saks, S., … Gutterman, J. U. (1990). A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity. J Biol Response Mod, 9(5), 522–527.
Abbruzzese, J. L., B. Levin, J. A. Ajani, J. S. Faintuch, R. Pazdur, S. Saks, C. Edwards, and J. U. Gutterman. “A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity.J Biol Response Mod 9, no. 5 (October 1990): 522–27.
Abbruzzese JL, Levin B, Ajani JA, Faintuch JS, Pazdur R, Saks S, Edwards C, Gutterman JU. A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity. J Biol Response Mod. 1990 Oct;9(5):522–527.

Published In

J Biol Response Mod

ISSN

0732-6580

Publication Date

October 1990

Volume

9

Issue

5

Start / End Page

522 / 527

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Severity of Illness Index
  • Recombinant Proteins
  • Middle Aged
  • Male
  • Interferon-gamma
  • Humans
  • Gastrointestinal Neoplasms
  • Female
  • Drug Evaluation