NCT02864888

Brief Summary

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).

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
30mo left

Started Jun 2027

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
10.8 years until next milestone

Study Start

First participant enrolled

June 1, 2027

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

August 9, 2016

Last Update Submit

September 15, 2025

Conditions

Brain Stem Glioma

Keywords

Diffuse, intrinsic brain stem gliomaQT/QTc intervalRadiationAntineoplaston therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with an Increase in the QTc interval

    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.

    6 weeks

Secondary Outcomes (1)

  • Number of participants with Alterations in T and U Wave Morphology

    6 weeks

Study Arms (2)

Radiation

EXPERIMENTAL

Study subjects receive a single daily radiation fraction of 180cGy, 5 days a week, for the 2 weeks of the QT/QTc study and for 6 weeks overall to a total radiation dose of 1600 cGy and 5400cGy, respectively.

Radiation: Radiation

Antineoplaston therapy + Radiation

EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 24 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.Study subjects also receive a single daily radiation fraction of 180cGy, 5 days a week, for the 2 weeks of the QT/QTc study and for 6 weeks overall to a total radiation dose of 1600 cGy and 5400cGy, respectively.

Radiation: RadiationDrug: AtengenalDrug: Astugenal

Interventions

RadiationRADIATION

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

Antineoplaston therapy + RadiationRadiation
AtengenalDRUG

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

Also known as: A10
Antineoplaston therapy + Radiation
AstugenalDRUG

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

Also known as: AS2-1
Antineoplaston therapy + Radiation

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in BRI-BT-52

You may not qualify if:

  • Not enrolled in BRI-BT-52

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Childs Nerv Syst. 2014 Dec;30(12):2051-61. doi: 10.1007/s00381-014-2401-z. Epub 2014 Apr 10.

    PMID: 24718705BACKGROUND

  • Burzynski SR. Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 5:379-390, 2007. Epub 2007 Nov

    BACKGROUND

  • Burzynski SR, Janicki TJ, Weaver RA, Burzynski B. Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther. 2006 Mar;5(1):40-7. doi: 10.1177/1534735405285380.

    PMID: 16484713BACKGROUND

Related Links

MeSH Terms

Interventions

Radiationantineoplaston A10

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Stanislaw R. Burzynski, MD, PhD

    Burzynski Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanislaw R Burzynski, MD, PhD

CONTACT

713-335-5664srb@burzynskiclinic.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share