Phase I clinical trial to determine maximum tolerated dose of oral albendazole in patients with advanced cancer
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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The maximum tolerated daily dose of albendazole was found to be 2,400 mg (for 14 days in a 21-day cycle) in 6 patients with advanced cancers, and myelosuppression, including neutropenia, leukopenia, lymphopenia, and thrombocytopenia, was the main dose limiting toxicity in 2 of the 6 patients.
“Further, the maximum tolerated daily dose of albendazole was found to be 2,400 mg (for 14 days in a 21-day cycle) in 6 patients with advanced cancers, and myelosuppression, including neutropenia, leukopenia, lymphopenia, and thrombocytopenia, was the main dose limting toxicity in 2 of the 6 patients [313].”
From Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update (2021) · cites this paper as [313]
However, 3 of 18 patients given 2,000-2,400 mg daily for 14 days developed neutropenia and other myelosuppression signs.
“However, 3 of 18 patients given 2,000–2,400 mg daily for 14 days developed neutropenia and other myelosuppression signs [313].”
From Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update (2021) · cites this paper as [313]
In a phase 1 clinical trial involving 36 solid tumor patients refractory to conventional anti-cancer therapies, the maximum tolerated dose of oral albendazole found was 2,400 mg per day (1,200 mg b.i.d.), and the recommended dose for further study was 2,400 mg daily for 14 days in a 21-day cycle.
“The maximum tolerated dose of oral albendazole found in these patients was 2,400 mg per day (1,200 mg b.i.d.), and the recommended dose for further study was 2,400 mg daily for 14 days in a 21-day cycle [313].”
From Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update (2021) · cites this paper as [313]
Myelosuppression, including neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia, were seen in patients given albendazole at the daily dose of 2,400 mg which were found to be the main dose limiting toxicity.
“Myelosuppression, including neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia, were seen in patients given albendazole at the daily dose of 2,400 mg which were found to be the main dose limiting toxicity [313].”
From Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update (2021) · cites this paper as [313]
Cites
Albendazole, mebendazole and praziquantel. Review of non-clinical toxicity and pharmacokinetics
Dayan, A. D. (2003) · Acta Tropica · doi:10.1016/s0001-706x(03)00031-7 · Cited by 371 · see citing works
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Drug repositioning: a machine-learning approach through data integration
Napolitano, F., Zhao, Y., Moreira, V. M., Tagliaferri, R., Kere, J., D’Amato, M., & Greco, D. (2013) · Journal of Cheminformatics · doi:10.1186/1758-2946-5-30 · Cited by 349 · see citing works
Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update
Chai, J.-Y., Jung, B.-K., & Hong, S.-J. (2021) · The Korean Journal of Parasitology · doi:10.3347/kjp.2021.59.3.189 · Cited by 286 · see citing works
Repurposing of Benzimidazole Anthelmintic Drugs as Cancer Therapeutics
Song, B., Park, E. Y., Kim, K. J., & Ki, S. H. (2022) · Cancers · doi:10.3390/cancers14194601 · Cited by 55 · see citing works
- Authors
- Pourgholami, M. H., Szwajcer, M., Chin, M., Liauw, W., Seef, J., Galettis, P., Morris, D. L., & Links, M.
- Affiliations
- UNSW Sydney (AU)
- St George Hospital (AU)
- Corresponding author
- Links, Matthew
- ORCID
- Venue
- Cancer Chemotherapy and Pharmacology
- Published
- 2009-11-11
- Volume
- 65
- Issue
- 3
- Pages
- 597-605
- ISSN
- 0344-5704 (ISSN-L)
- 1432-0843
- OpenAlex
- W2047104647
- Cited by
- 69
- References
- 1
- Citations by year
- 2026: 4 · 2025: 1 · 2023: 6 · 2022: 7 · 2021: 8 · 2020: 4 · 2019: 4 · 2018: 3 · 2017: 5 · 2016: 3 · 2015: 6 · 2014: 1 · 2013: 4 · 2012: 6
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Cancer Chemotherapy and Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- albendazole, maximum tolerated dose, advanced cancer, refractory solid tumors, myelosuppression, dose-limiting toxicity, fatigue, gastrointestinal adverse effects, tumor marker response, vascular endothelial growth factor, oral anticancer drugs, dose escalation
- MeSH terms
- Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Diarrhea, Dose-Response Relationship, Drug, Drug Administration Schedule, Fatigue, Female, Humans, Male, Metabolic Clearance Rate, Middle Aged, Nausea, Neoplasms, Pain, Albendazole, Treatment Outcome, Area Under Curve
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