Clinical effects and toxicity of interleukin-2 in patients with cancer

Cancer. 1986 Dec 15;58(12):2764-72. doi: 10.1002/1097-0142(19861215)58:12<2764::aid-cncr2820581235>;2-z.


Interleukin-2 (IL-2) is a 15,000 dalton glycoprotein produced naturally by human T-cells during an immune response. IL-2 has been demonstrated to have substantial activity alone or in combination with the adoptive transfer of lymphokine-activated killer cells in murine tumor models. IL-2 derived from both natural (Jurkat human T-cell tumor) and recombinant (Escherichia coli) sources has been studied in Phase I protocols designed to evaluate toxicity in patients with a variety of solid tumors and to ascertain improvement in clinical parameters and immunologic status. A total of 16 patients (7 with acquired immune deficiency syndrome [AIDS] and 9 with non-AIDS malignancies) were treated with Jurkat derived IL-2. The total maximum dose (1.3 X 10(5) U/kg) was limited only by supply of this reagent. A total of 25 patients have been treated with recombinant IL-2 (RIL-2) alone. Dose-limiting toxicity manifested by marked malaise and weight gain was achieved with doses of RIL-2 of 10(6) U/kg as a single bolus or 3000 U/kg/hr. IL-2 could be administered intraperitoneally with similar toxicity. Minimal renal or hepatic toxicity was demonstrated. Hematologic toxicity was limited to mild anemia (25/25), thrombocytopenia (10/25), and marked reversible eosinophilia (15/25). Pronounced weight gain greater than 2 kg (16/25) occurred in most patients, primarily those who received cumulative doses of greater than 1-3 X 10(5) U/kg of IL-2. The weight gain amounted to as much as 10% to 20% of the pretreatment weight over 3 weeks of treatment and limited our ability to give higher doses. Two partial responses (greater than 50% decrease in cross sectional diameters) were seen in two patients with melanoma metastatic to the lung.

MeSH terms

  • Acquired Immunodeficiency Syndrome / therapy
  • Adult
  • Aged
  • Biopsy
  • Body Weight
  • Bone Marrow / drug effects
  • Evaluation Studies as Topic
  • Female
  • Humans
  • Interleukin-2 / administration & dosage
  • Interleukin-2 / therapeutic use*
  • Interleukin-2 / toxicity
  • Kidney / drug effects
  • Liver / drug effects
  • Male
  • Middle Aged
  • Neoplasms / therapy*
  • Recombinant Proteins / therapeutic use
  • Recombinant Proteins / toxicity
  • Skin / pathology


  • Interleukin-2
  • Recombinant Proteins