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NOT YET RECRUITING
NCT02864888
PHASE3

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

Sponsor: Burzynski Research Institute

View on ClinicalTrials.gov

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).

Official 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

Key Details

Gender

All

Age Range

3 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-06

Completion Date

2029-12

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

RADIATION

Radiation

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

DRUG

Atengenal

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

DRUG

Astugenal

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