Clinical trial · Interventional
A Study of Atengenal and Astugenal in Diffuse, Intrinsic Pontine Glioma (DIPG)
A Phase 2 Study of Atengenal (A-10) and Astugenal (AS2-1) in Diffuse, Intrinsic Pontine Glioma (DIPG)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Clinical Hold
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse, Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antineoplaston therapy (Atengenal + Astugenal) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antineoplaston therapy
- description
- Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for up to 104 days. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached, but not exceeding 12.0 g/kg/d Atengenal or 0.4 mg/kg/d Astugenal.
- interventionNames
- Drug: Antineoplaston therapy (Atengenal + Astugenal)
Primary outcomes (1)
- measure
- Efficacy Measured by Objective Response Rate
- timeFrame
- 104 weeks
- description
- Objective Response Rate
Secondary outcomes (1)
- measure
- Efficacy Measured by Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Five cohorts of patients with diffuse, intrinsic pontine glioma will be studied: 1. Patients age 3 months to \< 3 years; 2. Patients age 3-21 years with progressive disease (PD) following radiation therapy (RT) ± chemotherapy and/or other therapies; 3. Patients age 3-21 years with newly diagnosed DIPG who (or whose parents / guardians) have refused RT; 4. Patients age \> 21 years with PD following RT ± chemotherapy and/or other therapies; and 5. Patients age \> 21 years with newly diagnosed DIPG who have refused RT. Exclusion Criteria include: 1. Disseminated disease, multicentric tumors, or leptomeningeal disease; 2. Uncontrolled intercurrent illness; 3. A history of New York Heart Association Class II congestive heart failure or above; 4. Pregnancy.
References
Publications (0)
Data not yet available