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

Study acronym: DBSG
StatusNot Yet Recruiting
PhasePhase 3
Started2027-06
View on ClinicalTrials.gov ↗
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).

Amendment record

Amended 10 times since 2016-08-09; most recent filed 2025-09-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2025-09-15
Amendment Study Status v10
2024-08-10
Amendment Study Status v9
2023-03-06
Amendment Study Status v8
2021-07-19
Amendment Study Status v7
2021-01-31
Amendment Study Status v6
2020-01-14
Amendment Study Status v5
2018-10-14
Amendment Study Status v4
2017-09-26
Amendment Study Status v3
2017-07-18
Amendment Study Status, Oversight, Study Design v2
2016-08-18
Amendment Study Identification, Study Status, Arms and Interventions, References v1
2016-08-09
Original filing
Trial Details
NCT Number NCT02864888
Lead Sponsor Burzynski Research Institute
Conditions Brain Stem Glioma
Enrollment 30 participants
Start Date 2027-06
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-19