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NCT02864888: DBSG
A Controlled, Study of the Effect of Combination Antineoplaston Therapy [Atengenal (A10) and Astugenal (AS2-1)] on the QT/QTc Interval In Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma
Phase 3 trial testing Radiation in Brain Stem Glioma in 30 participants. Not yet recruiting.
1 December 2029
Quick facts
| Lead sponsor | Burzynski Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 1 June 2027 |
| Primary completion | 1 December 2029 |
| Estimated completion | 1 December 2029 |
Drugs / interventions tested
Conditions studied
- Brain Stem Glioma — all drugs for Brain Stem Glioma →
Sponsor
Burzynski Research Institute
Who can join
Adults 3 to 21, any sex, with Brain Stem Glioma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants with an Increase in the QTc interval
Time frame: 6 weeks
The mean maximum increase in QTc interval, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02864888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Brain Stem Glioma
Currently open trials in the same condition.
- NCT00840047 — Methionine PET/CT Studies In Patients With Cancer · Phase 2 · active not recruiting
Other Burzynski Research Institute trials
Trials by the same sponsor.
- NCT00003512 — Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia · Phase 2 · withdrawn
- NCT00003498 — Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma · Phase 2 · terminated
- NCT00003522 — Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine · Phase 2 · terminated
- NCT00003513 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma · Phase 2 · terminated
- NCT00003515 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02864888 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Burzynski Research Institute
- Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02864888.
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