Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00003476 · ClinicalTrials.gov registry record · Phase 2
Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
A Phase 2 study, sponsored by Burzynski Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00003476: Clinical Trial Phase 2 study, sponsored by Burzynski Research Institute.
NCT00003476 is a Phase 2 study that was terminated before completion, run by Burzynski Research Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003476, a Phase 2 study, was terminated before completion, sponsored by Burzynski Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
RATIONALE: Current therapies for children with primary malignant brain tumors 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 primary malignant brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with primary malignant brain tumors.
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; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular dia
Interventions
- DRUG Antineoplaston therapy (Atengenal + Astugenal)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 1996-03 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
Why NCT00003476 stopped before completion
NCT00003476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.
NCT00003476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003476 about?
NCT00003476 is a clinical study titled "Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors". RATIONALE: Current therapies for children with primary malignant brain tumors 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 primary malignant brain tumors. PURPOSE: This study is be...
What is the current status of trial NCT00003476?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 1996-03. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00003476?
The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).
Who is sponsoring clinical trial NCT00003476?
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 NCT00003476's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia