Phase I clinical trial to determine maximum tolerated dose   of oral albendazole in patients with advanced cancer.
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.
Pourgholami
Mohammad H
MH
Cancer Pharmacology and Therapeutics, St George Hospital Cancer Care, and Department of Surgery, St George Clinical School, University of New South Wales, Sydney, Australia.
Szwajcer
Michael
M
Chin
Melvin
M
Liauw
Winston
W
Seef
Jonathan
J
Galettis
Peter
P
Morris
David L
DL
Links
Matthew
M
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
D000970:Antineoplastic Agents; D015766:Albendazole