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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
Open accessAbstract
PURPOSE: This phase I clinical trial evaluated the safety, tolerability, and pharmacokinetics of high-dose intravenous (i.v.) ascorbic acid as a monotherapy in patients with advanced solid tumors refractory to standard therapy. METHODS: Five cohorts of three patients received i.v. ascorbic acid administered at 1 g/min for 4 consecutive days/week for 4 weeks, starting at 30 g/m² in the first cohort. For subsequent cohorts, dose was increased by 20 g/m² until a maximum tolerated dose was found. RESULTS: Ascorbic acid was eliminated by simple first-order kinetics. Half-life and clearance values were similar for all patients of all cohorts (2.0 ± 0.6 h, 21 ± 5 dL/h m², respectively). C(max) and AUC values increased proportionately with dose between 0 and 70 g/m², but appeared to reach maximal values at 70 g/m² (49 mM and 220 h mM, respectively). Doses of 70, 90, and 110 g/m² maintained levels at or above 10-20 mM for 5-6 h. All doses were well tolerated. No patient demonstrated an objective antitumor response. CONCLUSIONS: Ascorbic acid administered i.v. at 1 g/min for 4 consecutive days/week for 4 weeks produced up to 49 mM ascorbic acid in patient's blood and was well tolerated. The recommended dose for future studies is 70-80 g/m².
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Phase I clinical trial of i.v. ascorbic acid in advanced malignancy
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Metadata
- Authors
- Stephenson, C. M., Levin, R. D., Spector, T., & Lis, C. G.
- Venue
- Cancer Chemotherapy and Pharmacology
- Published
- 2013-05-14
- Volume
- 72
- Issue
- 1
- Pages
- 139-146
- ISSN
- 0344-5704 (ISSN-L)
- 1432-0843
- OpenAlex
- W2160014667
- Cited by
- 264
- References
- 36
- FWCI
- 13.64
- Type
- journal article
- Language
- en
- Open access
- hybrid
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