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  • Title: Phase I--II study of N4-behenoyl-1-beta-D-arabinofuranosylcytosine.
    Author: Kimura K, Yamada K, Uzuka Y, Maekawa T, Takaku F, Shimoyama M, Ogawa M, Amaki I, Osamura S, Ito M, Sakai Y, Oguro M, Hattori K, Hoshino A, Hirota Y, Ohta K, Nakamura T, Masaoka T, Kimura I, Ichimaru M.
    Journal: Recent Results Cancer Res; 1981; 76():232-40. PubMed ID: 7232852.
    Abstract:
    A phase I-II study of N4-behenoyl-1-beta-D-arabinofuranosyl-cytosine (BH-AC) was conducted by a cooperative study group. In phase I study, a total of 126 patients, 64 of whom had metastatic solid tumors and 62 of whom had leukemia, were administered BH-AC in a single IV dose at day 1 only or in daily IV doses for 3 to 21 days, with dose ranges of 1.5--10.0 mg/kg. Side effects included nausea and vomiting, which were significantly less in incidence and severity than those observed with ara-C. Myelosuppressive toxicity became severe with doses 3.6--5.0 mg/kg per day x 10 days. In phase II study, a total of 37 adult patients with acute leukemia were entered in the study. Responses were noted, with an overall rate of 35% complete remission. Of th 26 patients with AML, there were 13 CR. The recommended schedule of treatment for BH-AC, based on our data, is daily infusion of 4--5 mg/kg over 3 h for approximately 3 weeks. The results with BH-AC in patients with acute leukemia are superior to those which have been reported for ara-C.
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