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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Number of Participants with an Increase in the QTc interval
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in BRI-BT-52
排除标准
- •Not enrolled in BRI-BT-52
研究组 & 干预措施
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.
干预措施: Radiation (Radiation)
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.
干预措施: Radiation (Radiation)
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.
干预措施: Atengenal (Drug)
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.
干预措施: Astugenal (Drug)
结局指标
主要结局
Number of Participants with an Increase in the QTc interval
时间窗: 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.
次要结局
- Number of participants with Alterations in T and U Wave Morphology(6 weeks)