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Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of high-dose intravenous ascorbic acid in patients with advanced cancer

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Phase I trial evaluates pharmacokinetics and safety of intravenous ascorbic acid in advanced cancer, suggesting tolerance to high doses.

This trial aimed to evaluate the safety and pharmacokinetics of high-dose intravenous ascorbic acid in patients with advanced solid tumors.
Phase I trial with five cohorts, three patients each; administered i.v. ascorbic acid at increasing doses starting from 30 g/m².
Doses increased by 20 g/m² until a maximum tolerable dose was determined over four weeks.
Ascorbic acid was given at a rate of 1 g/min for four consecutive days per week.
Elimination followed first-order kinetics with similar half-life (2.0 ± 0.6 h) and clearance (21 ± 5 dL/h m²) across patients.
C(max) reached a maximum of 49 mM and AUC of 220 h mM at doses up to 70 g/m².
All doses were well tolerated, but no objective antitumor response was observed.

Stephenson et al. (2013) studied this question.

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