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Brain Stem Glioma clinical trials

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NCT ID: NCT02887040 Not yet recruiting - Brain Stem Glioma Clinical Trials

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

DIPG
Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02864888 Not yet recruiting - Brain Stem Glioma Clinical Trials

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

DBSG
Start date: June 2024
Phase: Phase 3
Study type: Interventional

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).