A phase II trial of recombinant tumor necrosis factor in patients with adenocarcinoma of the pancreas: a Southwest Oncology Group study

J Immunother (1991). 1991 Oct;10(5):376-8. doi: 10.1097/00002371-199110000-00010.

Abstract

Twenty-two evaluable patients with advanced adenocarcinoma of the pancreas, but without prior chemotherapy or immunotherapy, received recombinant tumor necrosis factor (rTNF). rTNF was given as an intravenous infusion over 30 min daily x 5, every 14 days, at a starting dose of 150 micrograms/m2/day. Toxicities included fevers/rigors, nausea/vomiting/anorexia, flu-like symptoms, hypotension, hyperglycemia, anemia, coagulopathy, hepatotoxicity, and hypertriglyceridemia. Laboratory evidence of disseminated intravascular coagulopathy occurred in 11 patients, with only 3 of these patients having clinical manifestations. Two patients suffered from pulmonary emboli. The high incidence of coagulopathy was felt to be, at least in part, disease related. No objective responses were observed with a 95% confidence interval of 0-15%.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adenocarcinoma / therapy*
  • Adult
  • Aged
  • Drug Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / therapy*
  • Recombinant Proteins / therapeutic use
  • Tumor Necrosis Factor-alpha / adverse effects
  • Tumor Necrosis Factor-alpha / therapeutic use*

Substances

  • Recombinant Proteins
  • Tumor Necrosis Factor-alpha