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Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma (DBSG)

B

Burzynski Research Institute

Status and phase

Begins enrollment in a year or more
Phase 3

Conditions

Brain Stem Glioma

Treatments

Radiation: Radiation
Drug: Atengenal
Drug: Astugenal

Study type

Interventional

Funder types

Other

Identifiers

NCT02864888
BRI-BT-53

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

3 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Enrolled in BRI-BT-52

Exclusion criteria

  • Not enrolled in BRI-BT-52

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Radiation
Experimental group
Description:
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.
Treatment:
Radiation: Radiation
Antineoplaston therapy + Radiation
Experimental group
Description:
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.
Treatment:
Drug: Astugenal
Drug: Atengenal
Radiation: Radiation

Trial contacts and locations

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Central trial contact

Stanislaw R Burzynski, MD, PhD

Data sourced from clinicaltrials.gov

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