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Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma

Study acronym: DIPG
StatusNot Yet Recruiting
PhasePhase 3
Started2025-10-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 16, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Patients ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma will be enrolled in this study. However, the primary objectives of this study are to 1) compare overall survival, the time from randomization to death from any cause, for study subjects 3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma who receive Antineoplaston therapy (Atengenal + Astugenal) + radiation therapy vs. radiation therapy alone and 2) describe the toxicity profile (all subjects) for Antineoplaston therapy + radiation therapy vs. radiation therapy alone. A secondary objective is to compare progression-free survival for study subjects 3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma treated with Antineoplaston therapy + radiation therapy vs. radiation therapy alone.

Amendment record

Amended 10 times since 2016-08-29; 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 2026-08-30.

2025-09-15
Amendment Study Status v10
2024-08-10
Amendment Study Status v9
2023-03-06
Amendment Study Status v8
2022-02-21
Amendment Study Status v7
2020-11-10
Amendment Study Status v6
2020-08-25
Amendment Study Status v5
2019-08-07
Amendment Study Status v4
2018-07-10
Amendment Study Status v3
2017-09-26
Amendment Study Status v2
2017-07-18
Amendment Study Status, Oversight, Study Design v1
2016-08-29
Original filing
Trial Details
NCT Number NCT02887040
Lead Sponsor Burzynski Research Institute
Conditions Brain Stem Glioma
Enrollment 92 participants
Start Date 2025-10-01
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-16