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Related Experiment Videos

Clinical studies with tumour necrosis factor.

D R Spriggs1, M L Sherman, E Frei

  • 1Laboratory of Clinical Pharmacology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Ciba Foundation Symposium
|January 1, 1987
PubMed
Summary

Tumour necrosis factor (TNF) cytotoxicity mechanisms are unknown. Early clinical trials show TNF has toxicities similar to other biological agents, with further Phase II studies needed to assess its cancer therapy value.

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Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • The precise mechanism of tumour necrosis factor (TNF) cytotoxicity is not yet understood.
  • Potential anti-tumour effects of TNF involve direct cytotoxicity, immunomodulation, or effects on tumour vasculature.

Purpose of the Study:

  • To review the current status of human recombinant TNF in clinical trials.
  • To assess the clinical toxicity and early efficacy of TNF in cancer therapy.

Main Methods:

  • Review of ongoing Phase I and early Phase II clinical trials of human recombinant TNF.
  • Analysis of reported clinical toxicities and preliminary response data.

Main Results:

  • Clinical trials are underway globally, but the maximum Phase II dose is not established.
  • Observed toxicities include systemic effects (fever, nausea) and abnormalities in liver function, blood pressure, neurological status, and blood counts.
  • Few clinical responses have been reported thus far.

Conclusions:

  • Further organized Phase II efficacy studies are required for TNF as a single agent and in combination therapies.
  • Assessment of TNF's value in cancer treatment necessitates completion of ongoing and future efficacy trials.

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