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NCT01081223 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
A Phase 1 study, sponsored by TVAX Biomedical.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01081223: Completed Phase 1 study, sponsored by TVAX Biomedical.
NCT01081223 is a Phase 1 study that has completed, run by TVAX Biomedical. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081223, a Phase 1 study, has completed, sponsored by TVAX Biomedical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
Primary Outcome
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
Interventions
- BIOLOGICAL Cancer vaccine plus immune adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01081223 record still lists
NCT01081223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Cancer vaccine plus immune adjuvant is the first listed.
NCT01081223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081223 about?
NCT01081223 is a clinical study titled "Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma". TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of tho...
What is the current status of trial NCT01081223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01081223?
The interventions under investigation include: Cancer vaccine plus immune adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01081223?
This trial is sponsored by TVAX Biomedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01081223's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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