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NCT00003474 · ClinicalTrials.gov registry record · Phase 2

Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

A Phase 2 study of Glioblastoma Multiforme of the Brain, sponsored by Burzynski Research Institute.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT00003474: Completed Phase 2 study of Glioblastoma Multiforme of the Brain, sponsored by Burzynski Research Institute.

NCT00003474 is a Phase 2 study of Glioblastoma Multiforme of the Brain 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003474, a Phase 2 study of Glioblastoma Multiforme of the Brain, has completed, sponsored by Burzynski Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Current therapies for Glioblastoma Multiforme 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 tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

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)

Study Locations (1)

Texas

  • Burzynski Clinic - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 1996-03-14
Est. Completion 2003-06-21
Phase Phase 2
Burzynski Research Institute

52 total trials

What the finished NCT00003474 record still lists

NCT00003474 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 1 condition, with Glioblastoma Multiforme of the Brain appearing as the primary indexed condition, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.

NCT00003474 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00003474 about?

NCT00003474 is a clinical study titled "Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme". RATIONALE: Current therapies for Glioblastoma Multiforme 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 tumors. PURPOSE: This study is being performed to determine the effects (good and...

What is the current status of trial NCT00003474?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 1996-03-14. Estimated completion is 2003-06-21.

What conditions does trial NCT00003474 study?

This clinical trial studies the following conditions: Glioblastoma Multiforme of the Brain.

What interventions are being tested in trial NCT00003474?

The interventions under investigation include: Antineoplaston therapy (Atengenal + Astugenal) (DRUG).

Who is sponsoring clinical trial NCT00003474?

This trial is sponsored by Burzynski Research Institute, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00003474 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00003474'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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Source: ClinicalTrials.gov NCT00003474, the US trial registry maintained by the National Library of Medicine. NCT00003474 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.