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NCT01752491

A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Completed Phase 1 Last updated 20 December 2024
What this trial tests

Phase 1 trial testing Ascorbate in Glioblastoma in 13 participants. Completed in 15 November 2019.

Timeline
1 April 2013
Primary endpoint
30 November 2015
15 November 2019

Quick facts

Lead sponsorJoseph J. Cullen, MD, FACS
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date1 April 2013
Primary completion30 November 2015
Estimated completion15 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Joseph J. Cullen, MD, FACS

Who can join

18 and older, any sex, with Glioblastoma or GBM. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. O<sub>2</sub><sup>⋅-</sup> and H<sub>2</sub>O<sub>2</sub>-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate.
    Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, et al · · 2017 · cited 298× · PMID 28366679 · DOI 10.1016/j.ccell.2017.02.018
  2. Radioresistance in Glioblastoma and the Development of Radiosensitizers.
    Ali MY, Oliva CR, Noman ASM, Allen BG, et al · · 2020 · cited 128× · PMID 32899427 · DOI 10.3390/cancers12092511
  3. O<sub>2</sub><sup>⋅-</sup> and H<sub>2</sub>O<sub>2</sub>-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate.
    Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, et al · · 2017 · cited 85× · PMID 28810149 · DOI 10.1016/j.ccell.2017.07.008
  4. Metabolic Regulation of Redox Balance in Cancer.
    Purohit V, Simeone DM, Lyssiotis CA. · · 2019 · cited 79× · PMID 31288436 · DOI 10.3390/cancers11070955
  5. Systematic Review of Intravenous Ascorbate in Cancer Clinical Trials.
    Nauman G, Gray JC, Parkinson R, Levine M, et al · · 2018 · cited 73× · PMID 30002308 · DOI 10.3390/antiox7070089
  6. Oxidative Stress and Age-Related Tumors.
    Di Carlo E, Sorrentino C. · · 2024 · cited 33× · PMID 39334768 · DOI 10.3390/antiox13091109
  7. Ascorbate as a Bioactive Compound in Cancer Therapy: The Old Classic Strikes Back.
    González-Montero J, Chichiarelli S, Eufemi M, Altieri F, et al · · 2022 · cited 18× · PMID 35744943 · DOI 10.3390/molecules27123818
  8. Clinical Targeting of Altered Metabolism in High-Grade Glioma.
    Scott AJ, Lyssiotis CA, Wahl DR. · · 2021 · cited 17× · PMID 34570453 · DOI 10.1097/ppo.0000000000000550

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Other trials of Ascorbate

Trials testing the same drug.

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