NCT02771743Unknown2 期
Response-based Treatment of High-risk Neuroblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Rate of event free survival
研究概览
简要总结
The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.
详细描述
Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.
In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed high risk neuroblastoma
- •Patients with informed consent
排除标准
- •Patients with progressive disease or relapse
- •Patients who underwent high dose chemotherapy before
- •Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%
- •Pregnant or nursing women
研究组 & 干预措施
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Cisplatin (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Doxorubicin (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Etoposide (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Cyclophosphamide (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Ifosfamide (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Carboplatin (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Tandem HDCT/auto-SCT (Procedure)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Radiotherapy (Radiation)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Interleukin-2 (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: Isotretinoin (Drug)
High risk neuroblastoma
Experimental
- Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
- Upfront surgery or surgery after 6 cycles of chemotherapy
- Peripheral stem cell mobilization after 7 cycles of chemotherapy
- Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
- Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
- Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
- Radiotherapy after tandem HDCT
- Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
干预措施: MIBG (Radiation)
结局指标
主要结局
Rate of event free survival
时间窗: Up to 3 years
次要结局
- Rate of late adverse effects(Up to 3 years)
研究者
研究点 (1)
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