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NCT00003537 · ClinicalTrials.gov registry record · Phase 2
Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
A Phase 2 study of Adult Brain Tumor, sponsored by Burzynski Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00003537: Completed Phase 2 study of Adult Brain Tumor, sponsored by Burzynski Research Institute.
NCT00003537 is a Phase 2 study of Adult Brain Tumor that has completed, run by Burzynski Research Institute. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003537, a Phase 2 study of Adult Brain Tumor, has completed, sponsored by Burzynski Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.
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
Conditions Studied
Interventions
- DRUG Antineoplaston therapy (Atengenal + Astugenal)
Study Locations (1)
Texas
- Burzynski Clinic - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 1995-04 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00003537 record still lists
NCT00003537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Adult Brain Tumor appearing as the primary indexed condition, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.
NCT00003537 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00003537 about?
NCT00003537 is a clinical study titled "Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma". RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. PURPOSE: This study is being performed to det...
What is the current status of trial NCT00003537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 1995-04. Estimated completion is 2008-10.
What conditions does trial NCT00003537 study?
This clinical trial studies the following conditions: Adult Brain Tumor.
What interventions are being tested in trial NCT00003537?
The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).
Who is sponsoring clinical trial NCT00003537?
This trial is sponsored by Burzynski Research Institute, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003537 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00003537's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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.
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