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Annals of Oncology Advance Access first published online on June 9, 2008
This version published online on July 25, 2008
Annals of Oncology, doi:10.1093/annonc/mdn377
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase I clinical trial of i.v. ascorbic acid in advanced malignancy

L. J. Hoffer1,*, M. Levine2, S. Assouline1, D. Melnychuk1, S. J. Padayatty2, K. Rosadiuk1, C. Rousseau1, L. Robitaille1 and W. H. Miller, Jr1

1 Montreal Centre for Experimental Therapeutics in Cancer, Lady Davis Institute for Medical Research, McGill University and the Jewish General Hospital, Montreal, Quebec, Canada
2 Molecular and Clinical Nutrition Section, Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA

* Correspondence to: Dr L. J. Hoffer, Lady Davis Institute for Medical Research, Jewish General Hospital, 3755 Cote-Ste-Catherine Road, Montreal, Quebec H3T 1E2, Canada. Tel: +1-514-340-8222; Fax: +1-514-340-7502; E-mail: l.hoffer{at}mcgill.ca

Background: Ascorbic acid is a widely used and controversial alternative cancer treatment. In millimolar concentrations, it is selectively cytotoxic to many cancer cell lines and has in vivo anticancer activity when administered alone or together with other agents. We carried out a dose-finding phase I and pharmacokinetic study of i.v. ascorbic acid in patients with advanced malignancies.

Patients and methods: Patients with advanced cancer or hematologic malignancy were assigned to sequential cohorts infused with 0.4, 0.6, 0.9 and 1.5 g ascorbic acid/kg body weight three times weekly.

Results: Adverse events and toxicity were minimal at all dose levels. No patient had an objective anticancer response.

Conclusions: High-dose i.v. ascorbic acid was well tolerated but failed to demonstrate anticancer activity when administered to patients with previously treated advanced malignancies. The promise of this approach may lie in combination with cytotoxic or other redox-active molecules.

antioxidants, vitamin C

The spelling of the fifth author, the legends for Figures 1 and 2, and the penultimate sentence of the Discussion have been corrected.

Received for publication March 28, 2008. Revision received April 25, 2008. Accepted for publication May 7, 2008.


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Results of study in line with predictions
Steve Hickey, et al.
Annals of Oncology, 18 Jun 2008 [Full text]
Re: Results of study in line with predictions
L. John Hoffer, et al.
Annals of Oncology, 30 Jul 2008 [Full text]
Re: Results of study in line with predictions
Sebastian J Padayatty, et al.
Annals of Oncology, 18 Sep 2008 [Full text]
Re: Re: Results of study in line with predictions
Leonardo A. Noriega, et al.
Annals of Oncology, 20 Nov 2008 [Full text]

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