Polyethylene glycol conjugated interleukin-2: Clinical and immunologic effects in patients with advanced renal cell carcinoma

Ronald M. Bukowski, James Young, Gary Goodman, Frederick J Meyers, Brian F. Issell, James S. Sergi, Denise McLain, Gwen Fyfe, James Finke

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Recombinant interleukin-2 (rIL-2) modified with monomethoxypolyethylene glycol (PEG IL-2) was utilized in patients with metastatic renal cell carcinoma in two separate multi-institutional trials. PEG IL-2 was administered as an I.V. bolus days 1, 8, 15, and 22 with cycles repeated every six weeks. The two trials employed different dose levels: A) 20x106 I.U./m2 day 1 followed by 12x106 I.U./m2 days 8, 15, 22; and B) 12x106 I.U./m2 days 1, 8, 15, 22. Thirty-five patients were entered and 31 were evaluable for response (A-15/18, B-16/17). Two of 31 patients had partial responses. Median therapy duration was four weeks (range 1-15), and dose reduction for grade III or IV toxicity was required in 14/35 patients (A-6/18, B-8/17). Toxicity (≥ grade III) seen included: hypotension 51%, dyspnea 17%, seizures 6%, and mental status changes 11%. No differences in response or toxicity between the two schedules were noted. Hematologic changes included lymphocytosis and eosinophilia in the majority of patients. PEG IL-2 given once weekly has significant toxicity, and may produce tumor regression in patients with renal cell carinoma.

Original languageEnglish (US)
Pages (from-to)211-217
Number of pages7
JournalInvestigational New Drugs
Volume11
Issue number2-3
DOIs
StatePublished - Jun 1993

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Keywords

  • PEG IL-2
  • phase II trial
  • renal cell carcinoma

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

Bukowski, R. M., Young, J., Goodman, G., Meyers, F. J., Issell, B. F., Sergi, J. S., McLain, D., Fyfe, G., & Finke, J. (1993). Polyethylene glycol conjugated interleukin-2: Clinical and immunologic effects in patients with advanced renal cell carcinoma. Investigational New Drugs, 11(2-3), 211-217. https://doi.org/10.1007/BF00874158