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01-02-2010 | Clinical Trial Report

Phase I clinical trial to determine maximum tolerated dose of oral albendazole in patients with advanced cancer

Authors: Mohammad H. Pourgholami, Michael Szwajcer, Melvin Chin, Winston Liauw, Jonathan Seef, Peter Galettis, David L. Morris, Matthew Links

Published in: Cancer Chemotherapy and Pharmacology | Issue 3/2010

Abstract

Purpose

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.

Patients and 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.

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Title: Phase I clinical trial to determine maximum tolerated dose of oral albendazole in patients with advanced cancer
Authors: Mohammad H. Pourgholami
Michael Szwajcer
Melvin Chin
Winston Liauw
Jonathan Seef
Peter Galettis
David L. Morris
Matthew Links
Publication date: 01-02-2010
Publisher: Springer-Verlag
Published in: Cancer Chemotherapy and Pharmacology / Issue 3/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-009-1157-8

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