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NCT02887040: DIPG
A Randomized Phase 3 Study of Combination Antineoplaston Therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] Plus Radiation Therapy vs. Radiation Therapy Only in Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma
Phase 3 trial testing Radiation in Brain Stem Glioma in 92 participants. Not yet recruiting.
1 June 2026
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 | treatment |
| Enrollment | 92 |
| Start date | 1 October 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2026 |
Drugs / interventions tested
Conditions studied
- Brain Stem Glioma — all drugs for Brain Stem Glioma →
Sponsor
Burzynski Research Institute
Who can join
Adults 3 to 99, 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.
-
Change in Percentage of Participants Who Survived (Overall Survival)
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
The Kaplan-Meier nonparametric method is used to evaluate overall survival in the two therapy groups. Survival difference is evaluated using a log-rank test, which compares the two therapy groups. A Cox proportional hazards model is used as a supportive analysis to assess the magnitude of difference between the two therapy groups. The median survival rate in the two therapy groups (and 95% confide
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Bench-to-bedside investigations of H3 K27-altered diffuse midline glioma: drug targets and potential pharmacotherapies.
Rechberger JS, Bouchal SM, Power EA, Nonnenbroich LF, et al · · 2023 · cited 3× · PMID 37897190 · DOI 10.1080/14728222.2023.2277232
Verify or expand the search:
- PubMed search for NCT02887040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06270888 — Hypofractionation (Radiation) Trial for Multiple Myeloma · Phase 1 · recruiting
- NCT06875583 — The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial · NA · recruiting
- NCT07046221 — Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery · Phase 2 · not yet recruiting
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 NCT02887040 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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/NCT02887040.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing