drugset
drugset / Trial / NCT02887040

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

NCT02887040 ↗

Phase 3 Not yet recruiting 92 enrolled Burzynski Research Institute
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2025-10-01
Primary completion
2026-06
Completion
2026-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Astugenal Unknown — Intravenous
Subject antineoplaston A10 Small molecule — Intravenous

Indications

brain stem glioma