Clinical trial
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
Name
BRI-BT-53
Description
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 arms
Trial start
2024-06-01
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Radiation
Children with a diffuse, intrinsic brain stem glioma will receive radiation.
Arms:
Antineoplaston therapy + Radiation, Radiation
Atengenal
Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
Arms:
Antineoplaston therapy + Radiation
Other names:
A10
Astugenal
Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation
Arms:
Antineoplaston therapy + Radiation
Other names:
AS2-1
Size
30
Primary endpoint
Number of Participants with an Increase in the QTc interval
6 weeks
Eligibility criteria
Inclusion Criteria:
* Enrolled in BRI-BT-52
Exclusion Criteria:
* Not enrolled in BRI-BT-52
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-03-08
1 organization
2 products
1 indication
Organization
Burzynski Research InstituteProduct
AtengenalIndication
Brainstem GliomaProduct
Astugenal