title: Phase I clinical trial to determine maximum tolerated dose   of oral albendazole in patients with advanced cancer.
abstract: OBJECTIVE
  Albendazole is a potential anticancer agent that is currently under development for the treatment of cancer. We carried out a dose-finding phase I study of oral albendazole in patients with advanced malignancies.
  
  
  METHODS
  Thirty-six patients with refractory solid tumors were enrolled. Albendazole was given orally on a day 1-14 of a 3 weekly cycle, starting at 400 mg BD with dose escalation until 1,200 mg BD. Serial blood samples were collected up to 96 h and also on day 8 of cycles 1 and 4.
  
  
  RESULTS
  The maximum tolerated dose was 2,400 mg per day (1,200 BD). Myelosuppression was the main dose limiting toxicity. Fatigue and mild gastrointestinal upset were the other major adverse effects. 4 out of 24 assessable patients (16%) had a tumor marker response with a fall of at least 50% from baseline values and another patient had a prolonged period of stable marker response. A decline in plasma vascular endothelial growth factor levels was observed.
  
  
  CONCLUSIONS
  Albendazole was well tolerated on the schedule tested in this trial. The results of this study suggest that the recommended dose for further study is 1,200 mg twice daily for 14 days in a 21-day cycle.
authors.affiliation: Cancer Pharmacology and Therapeutics, St George Hospital Cancer Care, and Department of Surgery, St George Clinical School, University of New South Wales, Sydney, Australia.
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Pourgholami
authors.forename: Michael
authors.initials: M
authors.lastname: Szwajcer
authors.forename: Melvin
authors.initials: M
authors.lastname: Chin
authors.forename: Winston
authors.initials: W
authors.lastname: Liauw
authors.forename: Jonathan
authors.initials: J
authors.lastname: Seef
authors.forename: Peter
authors.initials: P
authors.lastname: Galettis
authors.forename: David L
authors.initials: DL
authors.lastname: Morris
authors.forename: Matthew
authors.initials: M
authors.lastname: Links
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015766:Albendazole / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019540:Area Under Curve; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D010146:Pain / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015766:Albendazole