Phase I study of high-dose continuous-infusion recombinant interleukin-2 and autologous lymphokine-activated killer cells in patients with metastatic or unresectable malignant melanoma and renal cell carcinoma

J Natl Cancer Inst. 1990 Sep 5;82(17):1397-402. doi: 10.1093/jnci/82.17.1397.

Abstract

The current study was undertaken to determine the maximum tolerated dose of recombinant interleukin-2 (rIL-2) that could be administered as a continuous infusion in conjunction with autologous lymphokine-activated killer (LAK) cells. All 55 patients in this study received a priming dose of rIL-2 of 1.0 mg/m2 per day given as a continuous infusion over 4.5 days. Patients later received (days 11-16) one of three doses of rIL-2 per day (1.0, 1.25, or 1.50 mg/m2) in conjunction with LAK cells given on days 11, 12, and 14. Because of unacceptable toxicity occurring early in the LAK cell phase of therapy at the rIL-2 dose level of 1.50 mg/m2, we concluded that the maximum tolerated dose of rIL-2 given as a continuous infusion with LAK cells is 1.25 mg/m2 per day.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Renal Cell / therapy*
  • Combined Modality Therapy
  • Evaluation Studies as Topic
  • Female
  • Humans
  • Interleukin-2 / adverse effects
  • Interleukin-2 / therapeutic use*
  • Kidney Neoplasms / therapy*
  • Killer Cells, Lymphokine-Activated / immunology*
  • Male
  • Melanoma / therapy*
  • Middle Aged
  • Neoplasm Metastasis
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use

Substances

  • Interleukin-2
  • Recombinant Proteins