Treatment of recurrent malignant glioma by repeated intracerebral injections of human recombinant interleukin-2 alone or in combination with systemic interferon-alpha. Results of a phase I clinical trial

J Neurooncol. 1992 Jan;12(1):75-83. doi: 10.1007/BF00172459.

Abstract

Nine patients with a recurrent malignant glioma were treated with repeated intracavitary or intracerebroventricular injections of human recombinant interleukin-2 (rIL-2) alone or in combination with systemic interferon-alpha (IFN-alpha). Five patients received only rIL-2 and four were treated with rIL-2 plus subcutaneous injections of IFN-alpha. Therapy was administered on a Monday, Wednesday, Friday schedule for up to 10 weeks, beginning with a dose of 10,000 IU rIL-2/injection. Doses were escalated every two weeks until some toxicity was apparent. The maximum amount of rIL-2 any one patient in this group received was 580,000 IU. Patients on combination immunotherapy were held at an rIL-2 dosage of 10,000 IU while IFN-alpha, which began at 3 million IU, was escalated every other week up to 18 million IU/dose. They were then held at that IFN-alpha dosage and rIL-2 was increased to 50,000 IU. The total amount of rIL-2 and IFN-alpha any one in this group received was 510,000 IU and 417 million IU, respectively. Repeated injections of 10,000 IU rIL-2 were well-tolerated by all nine patients and no change in their functional status was seen. At doses at 50,000 IU rIL-2, increased edema around the tumor cavity was observed by MRI/CT scand in 3/5 patients and clinical side-effects in the form of somnolence and headache along with some morbidity specifically associated with tumor location were also seen. Patients receiving rIL-2+ IFN-alpha showed progressive fatigue, muscle weakness, and occasionally nausea. Two of these patients showed increased peritumoral edema on MRI/CT scan.(ABSTRACT TRUNCATED AT 250 WORDS)

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Brain Neoplasms / diagnostic imaging
  • Brain Neoplasms / surgery
  • Brain Neoplasms / therapy*
  • Drug Administration Schedule
  • Drug Evaluation
  • Female
  • Glioma / diagnostic imaging
  • Glioma / surgery
  • Glioma / therapy*
  • Humans
  • Injections
  • Injections, Intraventricular
  • Interferon Type I / administration & dosage
  • Interferon Type I / therapeutic use*
  • Interferon Type I / toxicity
  • Interleukin-2 / administration & dosage
  • Interleukin-2 / therapeutic use*
  • Interleukin-2 / toxicity
  • Male
  • Neoplasm Recurrence, Local
  • Recombinant Proteins / therapeutic use
  • Recombinant Proteins / toxicity
  • Tomography, X-Ray Computed

Substances

  • Interferon Type I
  • Interleukin-2
  • Recombinant Proteins