A phase II trial of concomitant interferon-alpha-2b and granulocyte-macrophage colony-stimulating factor in patients with advanced renal cell carcinoma

J Immunother Emphasis Tumor Immunol. 1995 Jan;17(1):58-61. doi: 10.1097/00002371-199501000-00007.

Abstract

This study was undertaken to test the hypothesis that the combination of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interferon-alpha-2b (INF-alpha) would have a favorable clinical impact on patients with advanced renal cell carcinoma. Fifteen patients were treated with INF-alpha, 5 million U/m2 three times a week and GM-CSF 5 micrograms/kg, subcutaneously, daily. Patients received two consecutive 4-week cycles and then restaged. There were no complete responses, two of 15 partial responses (13%), and 13 of 15 had no response (87%). Biological effects (eosinophilia and leukocytosis) were characteristically observed. The therapy was well tolerated, and most side effects were attributable to INF-alpha. The study failed to show that the addition of GM-CSF to INF-alpha would increase the response rate in patients with metastatic renal cell carcinoma by enhancement of macrophage tumoricidal activity.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Renal Cell / therapy*
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Immunotherapy
  • Interferon alpha-2
  • Interferon-alpha / therapeutic use*
  • Kidney Neoplasms / therapy*
  • Male
  • Middle Aged
  • Recombinant Proteins
  • Treatment Outcome

Substances

  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Granulocyte-Macrophage Colony-Stimulating Factor