Reversible renal toxicity resulting from high single doses of the new radiosensitizer gadolinium texaphyrin

David I. Rosenthal, Carlos R. Becerra, Robert D. Toto, David P. Carbone, Eugene P. Frenkel

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

Gadolinium (III) texaphyrin (Gd-Tex) (NSC 695238) is a potential radiation sensitizer that selectively localizes in tumors and is detectable by magnetic resonance imaging (MRI). In this single-dose phase I trial, reversible renal injury was the dose-limiting toxicity. This report details that renal injury. A single intravenous dose of Gd-Tex was followed 2 hours later by radiation therapy. The Gd-Tex dose was escalated in 13 patient cohorts. Doses ranged from 0.6 to 29.6 mg/kg. The maximum tolerated dosage (MTD) was 22.3 mg/kg. Three patients had grade II and one had grade III acute nonoliguric renal failure at the 22.3 and 29.6 mg/kg dose levels. The injury was always transient, and responded to fluid restriction and renal diet. In all patients, transient green discoloration including urine developed at doses ≥7.1 mg/kg. MRI studies demonstrated image enhancement in the liver, kidneys, and in primary and metastatic tumors in all patients receiving >5.4 mg/kg. It is important that the liver and kidneys be excluded from the radiation volume. Gd-Tex was well tolerated at doses below the MTD. It is important that the liver and kidneys be excluded from the radiation volume. We recommend that 16.7 mg/kg be used as the maximum single dose to obviate even low grade renal toxicity.

Original languageEnglish (US)
Pages (from-to)593-598
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume23
Issue number6
DOIs
StatePublished - Dec 1 2000

Keywords

  • Gadolinium
  • Radiation therapy
  • Radiosensitizers
  • Renal toxicity
  • Texaphyrin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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