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

Study Purpose

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.#46; radiation alone (BRI-BT-52).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Enrolled in BRI-BT-52.

Exclusion Criteria:

- Not enrolled in BRI-BT-52

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02864888
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Burzynski Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stanislaw R. Burzynski, MD, PhD
Principal Investigator Affiliation	Burzynski Research Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Stem Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Radiation

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.

Experimental: Antineoplaston therapy + Radiation

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.

Drug: - Atengenal

Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation

Drug: - Astugenal

Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Stanislaw R Burzynski, MD, PhD

[email protected]

713-335-5664

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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