---
title: Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma
nct_id: NCT02864888
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: Burzynski Research Institute
study_type: INTERVENTIONAL
primary_condition: Brain Stem Glioma
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02864888.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02864888"
ct_last_update_post_date: 2025-09-19
last_seen_at: "2026-05-12T07:01:23.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma

**Official Title:** 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

**NCT ID:** [NCT02864888](https://clinicaltrials.gov/study/NCT02864888)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Burzynski Research Institute
- **Conditions:** Brain Stem Glioma
- **Start Date:** 2027-06
- **Completion Date:** 2029-12
- **CT.gov Last Update:** 2025-09-19

## Brief 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).

## Detailed Description

QT/QTc interval prolongation is investigated during the first two weeks of subject participation in the parallel phase 3 study. The pre-cordial leads and lead II will be utilized to determine QT/QTc prolongation. Descriptive information is provided on changes in T and U wave morphologies. The percentage of subjects in each therapy group who have worsening of the T and U wave morphology is documented. Discrete U waves are excluded from the QT/QTc interval measurement. Except for the pre-therapy ECGs, all ECGs are performed during one ANP therapy infusion daily, that being an afternoon infusion to account for diurnal variation in the QT/QTc interval. The study subject is at rest in the supine position for 30 minutes prior to the ECG study. The baseline QTc is derived from 3 ECGs taken on day 1 during the hour preceding the first Antineoplaston therapy infusion or the first radiation session.

## Eligibility

- **Minimum age:** 3 Years
- **Maximum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Enrolled in BRI-BT-52

Exclusion Criteria:

* Not enrolled in BRI-BT-52
```

## Arms

- **Radiation** (EXPERIMENTAL) — Study subjects receive a single daily radiation fraction of 180cGy, 5 days a week, for the 2 weeks of the QT/QTc study and for 6 weeks overall to a total radiation dose of 1600 cGy and 5400cGy, respectively.
- **Antineoplaston therapy + Radiation** (EXPERIMENTAL) — Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 24 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.Study subjects also receive a single daily radiation fraction of 180cGy, 5 days a week, for the 2 weeks of the QT/QTc study and for 6 weeks overall to a total radiation dose of 1600 cGy and 5400cGy, respectively.

## Interventions

- **Radiation** (RADIATION) — Children with a diffuse, intrinsic brain stem glioma will receive radiation.
- **Atengenal** (DRUG) — Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
- **Astugenal** (DRUG) — Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Number of participants with Alterations in T and U Wave Morphology** _(time frame: 6 weeks)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02864888.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02864888*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*