A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Tumor Response (Response Rate)
研究概览
简要总结
To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
- •Adequate renal, liver and bone marrow function
- •Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
排除标准
- •Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
- •Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
- •Patients with uncontrolled infection
- •Patients who have received pemetrexed previously
- •Patients with pleural effusions or ascites
研究组 & 干预措施
Pemetrexed
干预措施: pemetrexed (Drug)
结局指标
主要结局
Percentage of Participants With Overall Tumor Response (Response Rate)
时间窗: baseline to measured progressive disease (up to 1 year)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.
次要结局
- Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug(every cycle (up to 2 years and 7 months))
- Pharmacogenomics - Measure the Response of Genes Related to Toxicity(baseline)