A Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR) of Participants by the presence of radiologically measurable CNS disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and/or CSF Sampling.
研究概览
简要总结
HITC001 is a single institution study to evaluate the efficacy of using a standardized protocol of surgery and radiation for patients with brain metastases in relapsed neuroblastoma.
详细描述
This clinical trial aims to establish a standardized protocol consisting of surgery and radiation for patients with brain metastases in relapsed neuroblastoma. This will be an adjunct study to NMTRC009 onto which patients will be enrolled to for treatment with precision therapy. This study will follow the efficacy, safety, and CNS progression-free survival of surgery and radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≤ 21 years at the time of study entry.
- •Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma.
- •Disease Status: Patients must have ONE of the following along with disease in the CNS:
- •Any episode of recurrent disease following completion of aggressive multi-drug frontline therapy.
- •Any episode of progressive disease during aggressive multi-drug frontline therapy.
- •Primary resistant/refractory disease detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocols.
- •Measurable or evaluable disease by Brain MRI.
- •Current disease state must be one for which there is currently no known curative therapy.
- •Meet all inclusion criteria for study NMTRC009
- •Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
排除标准
- •Meets all exclusion criteria for study NMTRC009
- •Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
结局指标
主要结局
Overall Response Rate (ORR) of Participants by the presence of radiologically measurable CNS disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and/or CSF Sampling.
时间窗: 3 years
To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria.
次要结局
- Progression Free Survival (PFS) interval for CNS lesions will be measured by days from start of treatment (surgery/radiation) to the date of any future progressive disease (PD) in CNS lesions per RESIST criteria.(3 years)
- Length of time that participants experience Overall Survival (OS)(8 years)
- Number of Participants with Adverse Events as a Measure of Safety(3 years)
研究者
Giselle Sholler
Beat Childhood Cancer Chair
Milton S. Hershey Medical Center