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NCT02742883
A Phase 2 Study of Atengenal (A-10) and Astugenal (AS2-1) in Diffuse, Intrinsic Pontine Glioma (DIPG)
Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Diffuse, Intrinsic Pontine Glioma in 1 participant. Suspended.
1 March 2028
Quick facts
| Lead sponsor | Burzynski Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 13 April 2016 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Antineoplaston therapy (Atengenal + Astugenal) — full drug profile →
Conditions studied
- Diffuse, Intrinsic Pontine Glioma — all drugs for Diffuse, Intrinsic Pontine Glioma →
Sponsor
Burzynski Research Institute
Who can join
Adults 3 Months to 99, any sex, with Diffuse, Intrinsic Pontine 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.
-
Efficacy Measured by Objective Response Rate
Time frame: 104 weeks
Objective Response Rate
Sponsor's own description
Current therapies for diffuse, intrinsic pontine glioma (DIPG) provide very limited benefit to the patient. The rationale for the use of Antineoplaston therapy in this protocol study derives from experience with subjects from prior Phase 2 studies and Compassionate Exemption patients treated with Antineoplaston therapy at the Burzynski Clinic. This study is designed to analyze the efficacy and safety of Antineoplaston therapy in five separate DIPG patient cohorts, which are defined by age and prior therapy. This is a two stage study with 20 patients in each cohort being enrolled in the first stage and an additional 20 patients being enrolled in the second stage, if pre-determined efficacy endpoints in the first stage are realized.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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The Integration of Biology Into the Treatment of Diffuse Intrinsic Pontine Glioma: A Review of the North American Clinical Trial Perspective.
Clymer J, Kieran MW. · · 2018 · cited 15× · PMID 29868485 · DOI 10.3389/fonc.2018.00169 -
Importance of immune monitoring approaches and the use of immune checkpoints for the treatment of diffuse intrinsic pontine glioma: From bench to clinic and vice versa (Review).
Scutti JAB. · · 2018 · cited 8× · PMID 29484440 · DOI 10.3892/ijo.2018.4283 -
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 NCT02742883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Antineoplaston therapy (Atengenal + Astugenal)
Trials testing the same drug.
- 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
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 NCT02742883 (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/NCT02742883.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing