CLINICAL AND PHARMACOLOGIC EVALUATION OF SPLIT-DOSE INTERMITTENT THERAPY WITH DIANHYDROGALACTITOL

  • 1 January 1982
    • journal article
    • research article
    • Vol. 66  (2) , 283-287
Abstract
Dianhydrogalactitol was administered as 2 1-h infusions separated by a 4-h period once every 5 wk to 21 patients with advanced solid tumors. Total doses ranged from 100 mg/m2 (50 mg/2 twice on a single day) to 160 mg/m2 (80 mg/m2 twice on a single day). Peak concentrations of drug at the end of a 1-h infusion ranged from 1.9-5.6 .mu.g/ml. Plasma elimination of dianhydrogalactitol was approximated best by a 2-compartment open model. The .alpha.-half-life was 3.9 .+-. 1.9 min; the .beta.-half-life was 31.3 .+-. 2.7 min. Dose-limiting hematologic toxicity was encountered at a total dose of 160 mg/m2, with leukopenia occurring more frequently than thrombocytopenia. Other toxic effects included mild to moderate nausea in most patients and 2 instances of moderate alopecia. One patient with large cell cancer of the lung had a partial regression lasting 2 mo.; 1 patient with a carcinoid in the thymus had a partial regression lasting 7 1/2 mo. A 3rd patient with a mixed adenocarcinoma-squamous cell carcinoma of the lung had improvement (30% decrease) in his pulmonary tumor for > 2 mo.

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