drugset / Trial / NCT02864888
Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma
RandomizedParallel-groupSingle-blindOther
Summary
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).
Timeline
- Start
- 2027-06
- Primary completion
- 2029-12
- Completion
- 2029-12
Publications
- Background Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Childs Nerv Syst. 2014 Dec;30(12):2051-61. doi: 10.1007/s00381-014-2401-z. Epub 2014 Apr 10.
- Background Burzynski SR. Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 5:379-390, 2007. Epub 2007 Nov
- Background Burzynski SR, Janicki TJ, Weaver RA, Burzynski B. Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther. 2006 Mar;5(1):40-7. doi: 10.1177/1534735405285380.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Astugenal | Unknown | — | Intravenous |
| Subject | antineoplaston A10 | Small molecule | — | Intravenous |