Immunization with interleukin-2 transfected melanoma cells. A phase I-II study in patients with metastatic melanoma

Hum Gene Ther. 1993 Jun;4(3):323-30. doi: 10.1089/hum.1993.4.3-323.

Abstract

The safety, tolerance and clinical effects of immunization with irradiated, allogeneic melanoma cells that express high levels of HLA-A1 and -A2 and secrete IL-2 after transfection with the Interleukin-2 gene, will be assessed in HLA-A1 or HLA-A2 positive melanoma patients with metastatic disease. As a pilot, the first 5-10 patients, if no immediate regression of tumor lesions are observed, will in addition to immunization with these allogeneic tumor cells receive recombinant IL-2 in relatively low doses during three consecutive weeks on an outpatient basis. If no clinical remissions are induced in these first 5-10 patients, subsequent 5-10 patients will receive the same dose of melanoma cells without additional rIL-2. Thereafter the dose of injected melanoma cells will be increased in every following 5-10 patients, but all subsequent patients will receive only IL-2 producing, allogeneic tumor cells, without the addition of rIL-2.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Clinical Protocols
  • Genetic Therapy*
  • Humans
  • Immunotherapy*
  • Interleukin-2 / administration & dosage
  • Interleukin-2 / genetics
  • Interleukin-2 / therapeutic use*
  • Melanoma / immunology
  • Melanoma / pathology
  • Melanoma / therapy*
  • Skin Neoplasms / genetics
  • Skin Neoplasms / pathology
  • Skin Neoplasms / therapy*
  • Transfection
  • Tumor Cells, Cultured / transplantation
  • Vaccination

Substances

  • Interleukin-2