Daily low-dose subcutaneous recombinant interleukin-2 by alternate weekly administration: antitumor activity and immunomodulatory effects

Am J Clin Oncol. 1998 Feb;21(1):48-53. doi: 10.1097/00000421-199802000-00011.


A phase II clinical trial of subcutaneous recombinant Interleukin 2 (rIL-2) given by 5 days pulses followed by a 9 days rest has been performed in patients affected by renal cell carcinoma, malignant melanoma and colorectal cancer. A total of 25 patients entered the study, completed at least six courses of treatment, and were evaluable for toxicity and response to treatment. This schedule of subcutaneous rIL-2 was well tolerated and no World Health Organization grade 3 side effects were observed. A 33.3% response rate was recorded in patients affected by renal cell carcinoma, although no major responses were achieved in patients with malignant melanoma and colorectal cancer. A durable increase of natural killer activity retained by poeripheral blood mononuclear cells was demonstrated in these patients and was paralleled by increased serum levels of interferon gamma and tumor necrosis factor a without changes of circulating interleukin-1d. It is concluded that this schedule of pulse administration of subcutaneous rIL-2 has antitumor activity in renal cell carcinoma and produces durable biomodulatory effects.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Renal Cell / blood
  • Carcinoma, Renal Cell / drug therapy*
  • Colorectal Neoplasms / blood
  • Colorectal Neoplasms / drug therapy*
  • Cytokines / blood
  • Drug Administration Schedule
  • Humans
  • Immunologic Factors / administration & dosage
  • Immunologic Factors / therapeutic use*
  • Injections, Subcutaneous
  • Interleukin-2 / administration & dosage
  • Interleukin-2 / therapeutic use*
  • Kidney Neoplasms / blood
  • Kidney Neoplasms / drug therapy*
  • Melanoma / blood
  • Melanoma / drug therapy*
  • Middle Aged
  • Recombinant Proteins / therapeutic use


  • Antineoplastic Agents
  • Cytokines
  • Immunologic Factors
  • Interleukin-2
  • Recombinant Proteins