Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030719
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy With or Without Filgrastim Before Surgery High-Dose Chemotherapy and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
High Risk Neuroblastoma Study 1 Of Siop-Europe
Status:
UNKNOWN
Status Verified Date:
2010-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery It is not yet known which treatment regimen is more effective in treating neuroblastoma
PURPOSE This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery high-dose chemotherapy and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma
PURPOSE This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery high-dose chemotherapy and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma
Detailed Description:
OBJECTIVES
Compare the efficacy of myeloablative therapy with busulfan and melphalan vs carboplatin etoposide and melphalan in terms of 3- and 5-year event-free survival EFS progression-free survival PFS and overall survival OS in patients with high-risk neuroblastoma
Compare the 3-year EFS in these patients treated with isotretinoin with or without monoclonal antibody Ch1418 after myeloablative therapy
Determine the response at metastatic sites after induction chemotherapy in these patients
Determine the effect of metastatic disease response after induction chemotherapy on EFS PFS and OS in these patients
Compare the toxicity and episodes of febrile neutropenia in patients treated with induction chemotherapy with or without filgrastim G-CSF
Determine the effect of elective hematopoietic support with G-CSF during induction chemotherapy on peripheral blood stem cell collection in these patients
Compare the acute and long-term toxic effects of the 2 myeloablative therapy regimens in these patients
Determine the effect of radiotherapy on pre-surgical tumor volume at the primary site on local control EFS PFS and OS in these patients
Determine the tolerability of isotretinoin with or without monoclonal antibody Ch1418 after myeloablative therapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage 2 or 3 with MycN amplification vs 4 Patients are randomized to 1 of 8 treatment arms
Arm I
Patients receive induction chemotherapy comprising vincristine IV carboplatin IV over 1 hour and etoposide IV over 4 hours on days 1 and 41 vincristine IV and cisplatin IV over 24 hours on days 11 31 51 and 71 and vincristine IV on days 21 and 61 and cyclophosphamide IV and etoposide over 4 hours on days 21 22 61 and 62 Patients receive filgrastim G-CSF subcutaneously on days 3-8 12-18 23-28 32-38 43-48 52-58 63-68 and 72 until peripheral blood stem cell PBSC collection
Patients undergo PBSC collection beginning on day 80 Patients then undergo surgery on day 95
Patients receive myeloablative therapy comprising oral busulfan 4 times daily on days -6 to -3 and melphalan IV over 15 minutes on day -2 Patients undergo PBSC infusion on day 0
Patients undergo radiotherapy in 14 fractions over 21 days
Beginning within 30 days after radiotherapy patients receive oral isotretinoin twice daily on days 1-14 Treatment repeats every 28 days for 6 courses
Arm II
Patients receive induction chemotherapy as in arm I but with no G-CSF Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I
Patients receive oral isotretinoin twice daily on days 1-14 and monoclonal antibody Ch1418 IV over 8 hours on days 1-5 Treatment repeats every 28 days for 6 courses for isotretinoin and every 28 days for 5 courses for monoclonal antibody Ch1418
Arm III
Patients receive induction chemotherapy and G-CSF as in arm I Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm IV
Patients receive induction chemotherapy as in arm II Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Arm V
Patients receive induction chemotherapy and G-CSF as in arm I
Patients receive myeloablative therapy comprising carboplatin IV continuously and etoposide IV continuously on days -7 to -4 and melphalan IV over 15 minutes on days -7 to -5 Patients undergo PBSC infusion on day 0
Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm VI
Patients receive induction chemotherapy as in arm II Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Arm VII
Patients receive induction chemotherapy and G-CSF as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm VIII
Patients receive induction chemotherapy as in arm II Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Patients on all treatment arms are followed every 6 months for 3 years and then annually for 2 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 175 patients per year will be accrued for this study
Compare the efficacy of myeloablative therapy with busulfan and melphalan vs carboplatin etoposide and melphalan in terms of 3- and 5-year event-free survival EFS progression-free survival PFS and overall survival OS in patients with high-risk neuroblastoma
Compare the 3-year EFS in these patients treated with isotretinoin with or without monoclonal antibody Ch1418 after myeloablative therapy
Determine the response at metastatic sites after induction chemotherapy in these patients
Determine the effect of metastatic disease response after induction chemotherapy on EFS PFS and OS in these patients
Compare the toxicity and episodes of febrile neutropenia in patients treated with induction chemotherapy with or without filgrastim G-CSF
Determine the effect of elective hematopoietic support with G-CSF during induction chemotherapy on peripheral blood stem cell collection in these patients
Compare the acute and long-term toxic effects of the 2 myeloablative therapy regimens in these patients
Determine the effect of radiotherapy on pre-surgical tumor volume at the primary site on local control EFS PFS and OS in these patients
Determine the tolerability of isotretinoin with or without monoclonal antibody Ch1418 after myeloablative therapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage 2 or 3 with MycN amplification vs 4 Patients are randomized to 1 of 8 treatment arms
Arm I
Patients receive induction chemotherapy comprising vincristine IV carboplatin IV over 1 hour and etoposide IV over 4 hours on days 1 and 41 vincristine IV and cisplatin IV over 24 hours on days 11 31 51 and 71 and vincristine IV on days 21 and 61 and cyclophosphamide IV and etoposide over 4 hours on days 21 22 61 and 62 Patients receive filgrastim G-CSF subcutaneously on days 3-8 12-18 23-28 32-38 43-48 52-58 63-68 and 72 until peripheral blood stem cell PBSC collection
Patients undergo PBSC collection beginning on day 80 Patients then undergo surgery on day 95
Patients receive myeloablative therapy comprising oral busulfan 4 times daily on days -6 to -3 and melphalan IV over 15 minutes on day -2 Patients undergo PBSC infusion on day 0
Patients undergo radiotherapy in 14 fractions over 21 days
Beginning within 30 days after radiotherapy patients receive oral isotretinoin twice daily on days 1-14 Treatment repeats every 28 days for 6 courses
Arm II
Patients receive induction chemotherapy as in arm I but with no G-CSF Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I
Patients receive oral isotretinoin twice daily on days 1-14 and monoclonal antibody Ch1418 IV over 8 hours on days 1-5 Treatment repeats every 28 days for 6 courses for isotretinoin and every 28 days for 5 courses for monoclonal antibody Ch1418
Arm III
Patients receive induction chemotherapy and G-CSF as in arm I Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm IV
Patients receive induction chemotherapy as in arm II Patients then undergo PBSC collection and surgery as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm I Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Arm V
Patients receive induction chemotherapy and G-CSF as in arm I
Patients receive myeloablative therapy comprising carboplatin IV continuously and etoposide IV continuously on days -7 to -4 and melphalan IV over 15 minutes on days -7 to -5 Patients undergo PBSC infusion on day 0
Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm VI
Patients receive induction chemotherapy as in arm II Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Arm VII
Patients receive induction chemotherapy and G-CSF as in arm I Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin as in arm I
Arm VIII
Patients receive induction chemotherapy as in arm II Patients receive myeloablative therapy and undergo PBSC infusion as in arm V Patients undergo radiotherapy as in arm I Patients receive isotretinoin and monoclonal antibody Ch1418 as in arm II
Patients on all treatment arms are followed every 6 months for 3 years and then annually for 2 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 175 patients per year will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20148 | None | None | None |
| SIOP-EUROPE-HR-NBL-1 | None | None | None |
| ESIOP | None | None | None |