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NCT01752491 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
A Phase 1 study, sponsored by Joseph J. Cullen, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01752491: Completed Phase 1 study, sponsored by Joseph J. Cullen, MD, FACS.
NCT01752491 is a Phase 1 study that has completed, run by Joseph J. Cullen, MD, FACS. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01752491, a Phase 1 study, has completed, sponsored by Joseph J. Cullen, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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).
Primary Outcome
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Interventions
- DRUG Temozolomide
- RADIATION Radiation therapy
- DRUG Ascorbate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-04-01 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
What the finished NCT01752491 record still lists
NCT01752491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT01752491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01752491 about?
NCT01752491 is a clinical study titled "A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme". 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).
What is the current status of trial NCT01752491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-04-01. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT01752491?
The interventions under investigation include: Temozolomide (DRUG), Radiation therapy (RADIATION), Ascorbate (DRUG).
Who is sponsoring clinical trial NCT01752491?
This trial is sponsored by Joseph J. Cullen, MD, FACS, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01752491's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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