A Phase I Trial of Intravenous Interleukin-6 in Patients with Advanced Cancer

J. Weber, H. Gunn, J. Yang, D. Parkinson, S. Topalian, D. Schwartzentruber, S. Ettinghausen, D. Levitt, S. A. Rosenberg

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45 Scopus citations


Eighteen patients were treated with escalating doses of recombinant, Escherchia coli-derived human interleukin-6 (IL-6) intravenously every 8 h. Therapy was given for two cycles of 7 days each separated by a week off therapy. Fevers and chills were observed in most patients. Mild renal and liver function abnormalities were noted at higher doses of IL-6. Dose-limiting toxicity was reached at 30 μg/kg i.v. every 8 h due to reversible neurotoxicity, but significant rapidly reversible anemia and hyperglycemia were seen at lower doses. Platelet counts, white blood cell counts, and acute phase reactant levels were substantially elevated. No antitumor responses were seen. A maximum tolerated dose of 10 μg/kg i.v. every 8 h for two 7-day cycles is recommended for future phase II trials.

Original languageEnglish (US)
Pages (from-to)292-302
Number of pages11
JournalJournal of Immunotherapy
Issue number4
StatePublished - May 1994


  • Advanced cancer.
  • IL-6
  • Phase I trial

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology
  • Cancer Research


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