Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025623
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
Sponsor:
European Infant Neuroblastoma Study Group - 1999
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
European Infant Neuroblastoma Study - Stage 4 With Bone Lung Pleura or CNS Involvement MYCN Not Amplified
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
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 Combining more than one drug and giving them before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma
Detailed Description:
OBJECTIVES
Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide doxorubicin and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation
Determine whether deletion of chromosome 1p or diploidytetraploidy are prognostic factors in these patients
Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients
OUTLINE This is a multicenter study
Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3 Treatment repeats every 21 days for 2 courses
Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy Patients with metastatic complete response CR undergo surgical resection of primary disease
Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5 doxorubicin IV over 6 hours on days 4 and 5 and vincristine IV on days 1 and 5 Treatment repeats every 21 days for 2 courses
After 2 courses of CADO chemotherapy patients with metastatic CR undergo surgical resection of primary disease Patients with residual disease receive 2 additional courses of CADO chemotherapy Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 4 years
Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide doxorubicin and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation
Determine whether deletion of chromosome 1p or diploidytetraploidy are prognostic factors in these patients
Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients
OUTLINE This is a multicenter study
Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3 Treatment repeats every 21 days for 2 courses
Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy Patients with metastatic complete response CR undergo surgical resection of primary disease
Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5 doxorubicin IV over 6 hours on days 4 and 5 and vincristine IV on days 1 and 5 Treatment repeats every 21 days for 2 courses
After 2 courses of CADO chemotherapy patients with metastatic CR undergo surgical resection of primary disease Patients with residual disease receive 2 additional courses of CADO chemotherapy Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 4 years
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-20125C | None | None | None |
| EURO-INF-NB-STUDY-1999-993 | None | None | None |