drugset / Trial / NCT01752491
A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
Phase 1
Completed
13 enrolled
Joseph J. Cullen, MD, FACS
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).
Timeline
- Start
- 2013-04-01
- Primary completion
- 2015-11-30
- Completion
- 2019-11-15
Publications
- Background Du J, Cullen JJ, Buettner GR. Ascorbic acid: chemistry, biology and the treatment of cancer. Biochim Biophys Acta. 2012 Dec;1826(2):443-57. doi: 10.1016/j.bbcan.2012.06.003. Epub 2012 Jun 20.
- Background Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
- Results Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | 15 g | Intravenous |
| Subject | Vitamin C | Other / unclassified | 25 g | Intravenous |
| Subject | Vitamin C | Other / unclassified | 50 g | Intravenous |
| Subject | Vitamin C | Other / unclassified | 62.5 g | Intravenous |
| Subject | Vitamin C | Other / unclassified | 75 g | Intravenous |
| Subject | Vitamin C | Other / unclassified | 87.5 g | Intravenous |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |