Phase I clinical and pharmacokinetic study of diethyldithiocarbamate as a chemoprotector from toxic effects of cisplatin

R. Qazi, A. Y.C. Chang, R. F. Borch, T. Montine, P. Dedon, J. Loughner, J. M. Bennett

Research output: Contribution to journalArticlepeer-review

Abstract

Diethyldithiocarbamate (DDTC) has been shown to provide protection against most clinically significant toxk effects from cisplatin (DDP) without inhibiting tumor response in a variety of murine animal models. We conducted a phase I clinical and pharmacokinetic study of DDTC in combination with DDP to establish the types and severity of toxic effects and to determine whether protection of normal tissues and tumors occurs. Twenty-two courses of DDP plus DDTC were given to 10 patients. No nephrotoxic effects were seen at DDP doses of 50-120 mg/m2, and three patients had amelioration of nausea and vomiting. Objective antitumor responses were observed. Dose-limiting toxic effects from DDTC occurred at 150 mg/kg; these consisted of numbness in the infusion arm often accompanied by severe diaphoresis, chest discomfort, and agitation during DDTC infusion. These toxic effects resolved spontaneously, however, after termination of the infusion. The preliminary results suggest that plasma levels of DDTC that provide excellent protection hi rodents were exceeded at the doses used in our clinical study without compromising antitumor response. [J Natl Cancer Inst 1988:80:1486-1488]

Original languageEnglish (US)
Pages (from-to)1486-1488
Number of pages3
JournalJournal of the National Cancer Institute
Volume80
Issue number18
DOIs
StatePublished - Nov 16 1988
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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