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NCT00003459 · ClinicalTrials.gov registry record · Phase 2
Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
A Phase 2 study, sponsored by Burzynski Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00003459: Completed Phase 2 study, sponsored by Burzynski Research Institute.
NCT00003459 is a Phase 2 study that has completed, run by Burzynski Research Institute. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003459, a Phase 2 study, has completed, sponsored by Burzynski Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.
Primary Outcome
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.
Interventions
- DRUG Antineoplaston therapy (Atengenal + Astugenal)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1996-03 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
What the finished NCT00003459 record still lists
NCT00003459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.
NCT00003459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003459 about?
NCT00003459 is a clinical study titled "Antineoplaston Therapy in Treating Patients With Brain Stem Glioma". RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. PURPOSE: This study is being performed to determine the effects (good a...
What is the current status of trial NCT00003459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 1996-03. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00003459?
The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).
Who is sponsoring clinical trial NCT00003459?
This trial is sponsored by Burzynski Research Institute, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003459's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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