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NCT Number: NCT02864888

Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma

The primary objective of this protocol study is to investigate the effect of Antineoplaston therapy on the QT/QTc interval in study subjects age 3 to 21 years with newly-diagnosed, diffuse, intrinsic brainstem glioma. This investigation is to be conducted in parallel with a phase 3 efficacy and safety study of combination Antineoplaston therapy + radiation vs. radiation alone (BRI-BT-52).

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Key information

Conditions

Brain Stem Glioma

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

QT/QTc interval prolongation is investigated during the first two weeks of subject participation in the parallel phase 3 study. The pre-cordial leads and lead II will be utilized to determine QT/QTc prolongation. Descriptive information is provided on changes in T and U wave morphologies. The percentage of subjects in each therapy group who have worsening of the T and U wave morphology is documented. Discrete U waves are excluded from the QT/QTc interval measurement. Except for the pre-therapy ECGs, all ECGs are performed during one ANP therapy infusion daily, that being an afternoon infusion to account for diurnal variation in the QT/QTc interval. The study subject is at rest in the supine position for 30 minutes prior to the ECG study. The baseline QTc is derived from 3 ECGs taken on day 1 during the hour preceding the first Antineoplaston therapy infusion or the first radiation session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in BRI-BT-52

Exclusion criteria

  • Not enrolled in BRI-BT-52

Treatment and study plan

Radiation

Radiation

Children with a diffuse, intrinsic brain stem glioma will receive radiation.

Atengenal

Drug

Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation

Other names: A10

Astugenal

Drug

Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation

Other names: AS2-1

Primary outcomes

  1. Number of Participants with an Increase in the QTc interval

    Time frame: 6 weeks

    The mean maximum increase in QTc interval, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group.

Secondary outcomes

  1. Number of participants with Alterations in T and U Wave Morphology

    Time frame: 6 weeks

    Alterations in T and U wave morphology, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group.

Study contacts

Contact information is provided by the study sponsor or research team.

Stanislaw R Burzynski, MD, PhD

CONTACT

[email protected]

713-335-5664

Sponsors and collaborators

Lead sponsor

Burzynski Research Institute

Other

Registry information

Official study title

A Controlled, Study of the Effect of Combination Antineoplaston Therapy [Atengenal (A10) and Astugenal (AS2-1)] on the QT/QTc Interval In Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma

Acronym: DBSG

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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