Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025610
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy 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 4S and Stage 4 No Bone Lung Pleura or CNS MYCN Not Amplified
Status:
COMPLETED
Status Verified Date:
2001-11
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 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma
PURPOSE Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma
Detailed Description:
OBJECTIVES
Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide doxorubicin and vincristine
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 are stratified according to age under 1 month vs over 1 month
Infants less than 1 month of age are further stratified according to Philadelphia score less than 1 vs at least 1 Infants over 1 month of age are also further stratified according to Philadelphia score less than 2 vs at least 2
Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy
VP-CARBO chemotherapy Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3 Treatment repeats every 21 days for 2 courses Patients with no response receive CADO chemotherapy
CADO chemotherapy Patients receive 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 a maximum of 4 courses
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 130 patients will be accrued for this study within 4 years
Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide doxorubicin and vincristine
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 are stratified according to age under 1 month vs over 1 month
Infants less than 1 month of age are further stratified according to Philadelphia score less than 1 vs at least 1 Infants over 1 month of age are also further stratified according to Philadelphia score less than 2 vs at least 2
Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy
VP-CARBO chemotherapy Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3 Treatment repeats every 21 days for 2 courses Patients with no response receive CADO chemotherapy
CADO chemotherapy Patients receive 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 a maximum of 4 courses
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 130 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-20125B | None | None | None |
| EURO-INF-NB-STUDY-1999-992 | None | None | None |