Phase I Clinical Trial of i.v. Ascorbic Acid in Advanced Malignancy

Ann Oncol. 2008 Nov;19(11):1969-74. doi: 10.1093/annonc/mdn377. Epub 2008 Jun 9.

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.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antioxidants / administration & dosage
  • Antioxidants / adverse effects
  • Antioxidants / pharmacokinetics
  • Ascorbic Acid / administration & dosage
  • Ascorbic Acid / adverse effects*
  • Ascorbic Acid / blood
  • Ascorbic Acid / pharmacokinetics
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Neoplasms / blood
  • Neoplasms / drug therapy*

Substances

  • Antioxidants
  • Ascorbic Acid