Response-based Treatment of High-risk Neuroblastoma
Phase 2
- Conditions
- Newly Diagnosed High Risk Neuroblastoma
- Interventions
- Procedure: Tandem HDCT/auto-SCTRadiation: RadiotherapyRadiation: MIBG
- Registration Number
- NCT02771743
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Patients with newly diagnosed high risk neuroblastoma
- Patients with informed consent
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High risk neuroblastoma Interleukin-2 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Tandem HDCT/auto-SCT 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Radiotherapy 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma MIBG 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Doxorubicin 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Etoposide 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Cisplatin 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Cyclophosphamide 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Ifosfamide 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Carboplatin 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin High risk neuroblastoma Isotretinoin 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. 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 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin
- Primary Outcome Measures
Name Time Method Rate of event free survival Up to 3 years
- Secondary Outcome Measures
Name Time Method Rate of late adverse effects Up to 3 years
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of