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NCT00003468 · ClinicalTrials.gov registry record · Phase 2
Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
A Phase 2 study, sponsored by Burzynski Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00003468: Completed Phase 2 study, sponsored by Burzynski Research Institute.
NCT00003468 is a Phase 2 study that has completed, run by Burzynski Research Institute. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003468, a Phase 2 study, has completed, sponsored by Burzynski Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade astrocytomas that have not responded to standard therapy PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with low grade astrocytomas that has not responded to standard therapy.
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 | 11 participants |
| Start Date | 1996-07 |
| Est. Completion | 2004-07 |
| Phase | Phase 2 |
What the finished NCT00003468 record still lists
NCT00003468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.
NCT00003468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003468 about?
NCT00003468 is a clinical study titled "Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma". RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade astrocytomas...
What is the current status of trial NCT00003468?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 1996-07. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00003468?
The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).
Who is sponsoring clinical trial NCT00003468?
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 NCT00003468's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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