Elsevier

Annals of Oncology

Volume 19, Issue 11, November 2008, Pages 1969-1974
Annals of Oncology

original article
phase I and pharmacokinetics
Phase I clinical trial of i.v. ascorbic acid in advanced malignancy

https://doi.org/10.1093/annonc/mdn377 Get rights and content
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Abstract

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.

Keywords

antioxidants
vitamin C

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