Weekly 24-hour continuous infusion interleukin-2 for metastatic melanoma and renal cell carcinoma: A phase I study

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Twenty-nine patients with biopsy-confirmed metastatic melanoma (17) or metastatic renal cell carcinoma (12) were treated with escalating doses of recombinant human interleukin-2 (IL-2) administered as weekly 24-h intravenous infusions. Patients received from 3 to 12 x 106 C.U./m2 (18-72 x 106 I.U./m2) weekly over a treatment period of 1 to 16 weeks, with a median of eight weekly cycles administered. Patients in all treatment groups experienced non-life-threatening systemic side effects consisting of fever, nausea, vomiting, fluid retention, and diarrhea. Grade III hypotension was seen in four of six patients (67%) at 12 x 106 C.U./m2, and represented the dose-limiting toxicity. Grade IV hypotension occurred in 1 of 14 patients at 6 x 106 C.U./m2; no other grade IV toxicities were observed. Grade III fever occurred in 3 of 11 patients(27%) treated at 3 x 106 C.U/m2, 3 of 14 patients (21%) at 6 x 106 C.U./m2, and 3 of 6 patients (50%) at 9 x 106 C.U./m2. An objective response was observed in 3 of 28 evaluable patients (10%): 1 complete response and 1 partial response in renal cell cancer, and 1 partial response in a melanoma-patient. We conclude that for future studies, the recommended dose of IL-2 given as a weekly 24-h infusion is 9 x 106 C.U./m2 and that a low rate of objective tumor response can be obtained in patients with melanoma and renal cell carcinoma using this regimen.

Original languageEnglish (US)
Pages (from-to)57-62
Number of pages6
JournalJournal of Immunotherapy
Issue number1
StatePublished - 1991



  • interleukin-2
  • metastatic melanoma
  • metastatic renal cell carcinoma
  • phase I study

ASJC Scopus subject areas

  • Cancer Research
  • Immunology
  • Pharmacology

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