Brain Stem Glioma
Conditions
Keywords
Diffuse, intrinsic brain stem glioma, QT/QTc interval, Radiation, Antineoplaston therapy
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.
Interventions
RADIATIONRadiation
Children with a diffuse, intrinsic brain stem glioma will receive radiation.
DRUGAtengenal
Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
DRUGAstugenal
Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation
Sponsors
Burzynski Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Enrolled in BRI-BT-52
Exclusion criteria
* Not enrolled in BRI-BT-52
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with an Increase in the QTc interval | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Alterations in T and U Wave Morphology | 6 weeks | Alterations in T and U wave morphology, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group. |
Contacts
Primary ContactStanislaw R Burzynski, MD, PhD
Outcome results
None listed