PHASE 1 TRIAL OF DIANHYDROGALACTITOL ADMINISTERED IV IN A WEEKLY SCHEDULE

  • 1 January 1976
    • journal article
    • research article
    • Vol. 60  (7) , 895-901
Abstract
Dianhydrogalactitol was given to 28 patients with a variety of advanced solid tumors on a weekly schedule in i.v. doses ranging from 2-80 mg/m2. No significant toxicity was encountered at doses up to 10 mg/m2 per wk for 4 wk. At higher doses mild to moderate nausea, vomiting and hematologic toxicity were noted. Thrombocytopenia was more common than granulocytopenia and frequently resolved more slowly. No adverse drug related effects on liver, renal, coagulation or cardiac function were seen. Although no patient had significant antitumor response (as strictly defined), objective improvement was noted in 2 patients, 1 with hypernephroma and the other with malignant melanoma. For phase II studies, a weekly dose of 70 mg/m2 is recommended for patients with normal hematopoiesis, with reduction by 25% (55 mg/m2) in patients with extensive prior radiation therapy, prior chemotherapy and/or widespread metastases to the bone.

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