Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 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 children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high grade gliomas.
详细描述
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 children with recurrent/progressive high grade gliomas.
OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for 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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy
- •Measurable tumor by MRI scan performed within two weeks prior to study entry
- •Male or female patients
- •Children 6 months to 17 years
- •Performance status: Karnofsky 60-100%
- •Life expectancy of at least 2 months
- •WBC greater than 1,500/mm^3
- •Platelet count greater than 50,000/mm^3
- •No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal
- •Must have recovered from adverse effect of previous therapy
- •At least 8 weeks elapsed since last dose of radiation
- •At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)
- •Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function
- •Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study
排除标准
- •Prior A10 and AS2-1 treatment
- •Severe heart disease
- •Uncontrolled hypertension
- •Lung disease
- •Hepatic failure
- •Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug.
- •Pregnant or nursing
- •Serious concurrent disease
- •Concurrent antineoplastic or immunomodulatory agents
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.
次要结局
- Percentage of Participants Who Survived(6 months, 12 months, 24 months)