title: Phase I study of DABIS maleate given once every 3 weeks.
abstract: DABIS maleate is an alkylating quaternary nitrogen. In a phase I study DABIS maleate was administered as a single intravenous infusion once every 3 weeks. 32 patients with solid tumours were studied, at least 3 per dose level (50-1400 mg/m2). Dose-limiting toxicity was severe paresthaesias in the face, around the mouth and in the tongue. Cerebellar ataxia developed at 750 mg/m2 or higher. Haematological toxicity was minimal. Nausea and vomiting were mild to moderate. No other non-haematological side-effects were noted. The recommended dose for phase II studies at once every 3 weeks is 750 mg/m2 intravenously as a 15 min infusion.
authors.affiliation: Department of Medical Oncology, Rotterdam Cancer Institute, The Netherlands.
authors.forename: M E
authors.initials: ME
authors.lastname: van der Burg
authors.forename: A S
authors.initials: AS
authors.lastname: Planting
authors.forename: G
authors.initials: G
authors.lastname: Stoter
authors.forename: C
authors.initials: C
authors.lastname: McDaniel
authors.forename: C J
authors.initials: CJ
authors.lastname: Vecht
authors.forename: J
authors.initials: J
authors.lastname: Verweij
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001643:Bridged Bicyclo Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019086:Bridged Bicyclo Compounds, Heterocyclic; D002524:Cerebellar Ataxia / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010292:Paresthesia / Q000139:chemically induced; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D001643:Bridged Bicyclo Compounds; D019086:Bridged Bicyclo Compounds, Heterocyclic; D000644:Quaternary Ammonium Compounds; C072879:NSC 262266