Crisnatol mesylate: Phase I dose escalation by extending infusion duration

Elizabeth A. Poplin, Guy G. Chabot, Richard L. Tuttle, Sol Lucas, William A. Wargin, Laurence H. Baker

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


Crisnatol mesylate is a rationally designed cytotoxic arylmethylamino-propanediol with broad spectrum cytotoxic activity. A phase I study with an unconventional escalation scheme was developed using a constant drug infusion rate (mg/m2/hr) and prolonging the infusion duration from 6 to 96 hours. Sixty-five patients received crisnatol at doses from 18 mg/m2 in 6 hrs to 3400 mg/m2 in 72 hours. The dose-limiting toxicity in two of five patients at 2700 mg/m2 and two of three patients at 3400 mg/m2 was neurologic and consisted of a syndrome of confusion, agitation, and disorientation. Phlebitis mandated the use of a central line. The mean terminal phase half-life (T1/2 β) was 3.3 hours with a total body clearance (CL) of 22.8 L/hr/m2 and a volume of distribution (Vdss) of 53 L/m2. The median steady-state peak plasma concentration (Css) at 2700 mg/m2/72 hours was 2.7 μg/ml and at 3400 mg/m2/72 hours was 3.8 μg/ml. No responses were seen. The maximum tolerated dose (MTD) on this schedule is 2700 mg/m2/72 hours in patients with no liver disease and good performance status.

Original languageEnglish (US)
Pages (from-to)41-47
Number of pages7
JournalInvestigational New Drugs
Issue number1
StatePublished - Feb 1991
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)


  • continuous
  • crisnatol
  • infusion
  • phase I


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