Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response of Complete Response or Partial Response
研究概览
简要总结
This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.
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
- •Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
- •Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)
- •Life expectancy ≥ 3 months
排除标准
- •Diagnosis of brainstem glioma
- •Concurrent administration of any other anti-tumor therapy
- •Pre-existing uncontrolled diarrhea
研究组 & 干预措施
Temozolomide + Irinotecan
干预措施: Irinotecan (Drug)
Temozolomide + Irinotecan
干预措施: Temozolomide (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response of Complete Response or Partial Response
时间窗: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.
次要结局
- Time to Treatment Failure (TTF)(Baseline to Date of Treatment Failure (Up to 1 Year))
- Time to Tumor Progression (TTP)(Baseline to Date of Progression (Up to 1 Year))
- Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment(Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma))
- Duration of Response(Baseline to Date of Tumor Response (Up to 1 Year))
- Overall Survival (OS)(Baseline to Date of Death (Up to 1 Year After Treatment))