Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00003458 · ClinicalTrials.gov registry record · Phase 2
Antineoplaston Therapy in Treating Children With Brain Tumors
A Phase 2 study, sponsored by Burzynski Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00003458: Completed Phase 2 study, sponsored by Burzynski Research Institute.
NCT00003458 is a Phase 2 study that has completed, run by Burzynski Research Institute. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003458, a Phase 2 study, has completed, sponsored by Burzynski Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
RATIONALE: Current therapies for childhood 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 childhood brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with 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.
Interventions
- DRUG Antineoplaston therapy (Atengenal + Astugenal)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 1996-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00003458 record still lists
NCT00003458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.
NCT00003458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003458 about?
NCT00003458 is a clinical study titled "Antineoplaston Therapy in Treating Children With Brain Tumors". RATIONALE: Current therapies for childhood 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 childhood brain tumors. PURPOSE: This study is being performed to determine the effects (good...
What is the current status of trial NCT00003458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 1996-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00003458?
The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).
Who is sponsoring clinical trial NCT00003458?
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 NCT00003458's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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 enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
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