Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Brain Tumors.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Response
研究概览
简要总结
RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with persistent or recurrent brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.
详细描述
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in adults with persistent or recurrent brain tumors.
OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.
To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
干预措施: Antineoplaston therapy (Atengenal + Astugenal) (Drug)
结局指标
主要结局
Number of Participants With Objective Response
时间窗: 12 months
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \< 50% decrease and \< 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.
次要结局
- Percentage of Participants Who Survived(6 months, 12 months, 24 months, 36 months, 48 months, 60 months)