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Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma
Sponsor: Burzynski Research Institute
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
Conditions
Interventions
Radiation
Children with a diffuse, intrinsic brain stem glioma will receive radiation.
Atengenal
Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
Astugenal
Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation