Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024193
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-09-13
Brief Title:
Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells Chemotherapy given before and after surgery followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma
PURPOSE Phase II trial to study the effectiveness of chemotherapy given before and after surgery followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma
PURPOSE Phase II trial to study the effectiveness of chemotherapy given before and after surgery followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma
Detailed Description:
OBJECTIVES
Determine the efficacy of induction chemotherapy followed by surgical resection and consolidation chemotherapy with autologous peripheral blood stem cell transplantation in patients with metastatic neuroblastoma
Determine the tolerability and feasibility of this regimen in these patients
Determine the medium and long-term results in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of courses 1 2 4 and 6 Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 2 hours on days 1-3 of induction courses 3 5 and 7 Patients also receive filgrastim G-CSF IV or subcutaneously once daily beginning on day 5 of courses 3 5 and 7 and continuing until blood counts recover Treatment repeats every 21 days
At the completion of induction chemotherapy patients undergo surgical resection Patients in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2 Autologous peripheral blood stem cells PBSC are reinfused on day 0 Patients with n-myc tumor amplification undergo radiotherapy at least 70 days after PBSC transplantation
Patients are followed every 6 months
PROJECTED ACCRUAL Approximately 15-45 patients will be accrued for this study
Determine the efficacy of induction chemotherapy followed by surgical resection and consolidation chemotherapy with autologous peripheral blood stem cell transplantation in patients with metastatic neuroblastoma
Determine the tolerability and feasibility of this regimen in these patients
Determine the medium and long-term results in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of courses 1 2 4 and 6 Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 2 hours on days 1-3 of induction courses 3 5 and 7 Patients also receive filgrastim G-CSF IV or subcutaneously once daily beginning on day 5 of courses 3 5 and 7 and continuing until blood counts recover Treatment repeats every 21 days
At the completion of induction chemotherapy patients undergo surgical resection Patients in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2 Autologous peripheral blood stem cells PBSC are reinfused on day 0 Patients with n-myc tumor amplification undergo radiotherapy at least 70 days after PBSC transplantation
Patients are followed every 6 months
PROJECTED ACCRUAL Approximately 15-45 patients 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 |
|---|---|---|---|
| CDR0000068899 | REGISTRY | None | None |
| SFOP-NB97 | None | None | None |
| EU-20106 | Registry Identifier | PDQ Physician Data Query | None |