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NCT00003453 · ClinicalTrials.gov registry record · Phase 2

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

A Phase 2 study, sponsored by Burzynski Research Institute.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT00003453: Clinical Trial Phase 2 study, sponsored by Burzynski Research Institute.

NCT00003453 is a Phase 2 study that was terminated before completion, run by Burzynski Research Institute. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003453, a Phase 2 study, was terminated before completion, sponsored by Burzynski Research Institute.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.

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

FieldValue
Enrollment Target 6 participants
Start Date 1996-08-21
Est. Completion 2011-07-05
Phase Phase 2
Burzynski Research Institute

52 total trials

Why NCT00003453 stopped before completion

NCT00003453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Antineoplaston therapy (Atengenal + Astugenal) is the first listed.

NCT00003453 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003453 about?

NCT00003453 is a clinical study titled "Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer". Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer PURPOSE: This study is being performed to determine the effect...

What is the current status of trial NCT00003453?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 1996-08-21. Estimated completion is 2011-07-05.

What interventions are being tested in trial NCT00003453?

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

Who is sponsoring clinical trial NCT00003453?

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

How this trial's enrollment target compares

Where NCT00003453's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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 NCT00003453, the US trial registry maintained by the National Library of Medicine. NCT00003453 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.