N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment
研究概览
简要总结
The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).
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
- 1 Year 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
- •HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and stage 4 in patients >18 months old.
- •No more than one prior cycle of chemotherapy.
- •Age <19 years old.
- •Signed informed consent indicating awareness of the investigational nature of this treatment.
排除标准
- •Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade
- •Inability to comply with protocol requirements.
- •Pregnancy is not an issue because all patients will be pre-adolescents.
研究组 & 干预措施
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Cyclophosphamide (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Topotecan (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Doxorubicin (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Vincristine (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Ifosfamide (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Etoposide (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Carboplatin (Drug)
Participants with newly-diagnosed HR-Neuroblastoma
This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of >1 to 12-year old, and a second cohort of extended age <19 years old. Both cohorts will be analyzed together.
干预措施: Mesna (Drug)
结局指标
主要结局
Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment
时间窗: 16 weeks
Adverse events will be graded using Common Toxicity Criteria Version 5.0 developed by the National Cancer Institute of the USA, events of all grades will be tabulated, for non-hematologic effects and hematologic effects on the patients in the safety set. The timing of cycles will also be described to assess any delay due to toxicity
次要结局
未报告次要终点