Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025597
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 - Unresectable Tumors 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 Giving a chemotherapy drug 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
Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide etoposide and carboplatin and cyclophosphamide doxorubicin and vincristine followed by surgery
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 symptomatic spinal cord involvement yes vs no
Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5 Treatment repeats every 14 days for 2 courses Patients eligible for surgery undergo surgical resection and then are removed from the study
Patients ineligible for surgery after 2 courses of initial chemotherapy but with at least 25 response to initial chemotherapy receive 2 additional courses of vincristine and cyclophosphamide Patients eligible for surgery undergo surgical resection and then are removed from the study
Patients ineligible for surgery after 2 additional courses of initial chemotherapy or with disease progression 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 eligible for surgery undergo surgical resection and then are removed from the study
Patients who remain ineligible for surgery or with disease progression after etoposide and carboplatin 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 2 courses Patients then undergo surgical resection or biopsy
Patients with symptomatic spinal cord compression receive initial treatment with etoposide and carboplatin as above Patients with improved symptoms and resectable disease after initial chemotherapy undergo surgical resection or biopsy Patients who remain ineligible for surgery or with no improvement in symptoms after initial chemotherapy receive cyclophosphamide doxorubicin and vincristine as above Patients then undergo surgical resection or biopsy
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 4 years
Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide etoposide and carboplatin and cyclophosphamide doxorubicin and vincristine followed by surgery
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 symptomatic spinal cord involvement yes vs no
Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5 Treatment repeats every 14 days for 2 courses Patients eligible for surgery undergo surgical resection and then are removed from the study
Patients ineligible for surgery after 2 courses of initial chemotherapy but with at least 25 response to initial chemotherapy receive 2 additional courses of vincristine and cyclophosphamide Patients eligible for surgery undergo surgical resection and then are removed from the study
Patients ineligible for surgery after 2 additional courses of initial chemotherapy or with disease progression 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 eligible for surgery undergo surgical resection and then are removed from the study
Patients who remain ineligible for surgery or with disease progression after etoposide and carboplatin 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 2 courses Patients then undergo surgical resection or biopsy
Patients with symptomatic spinal cord compression receive initial treatment with etoposide and carboplatin as above Patients with improved symptoms and resectable disease after initial chemotherapy undergo surgical resection or biopsy Patients who remain ineligible for surgery or with no improvement in symptoms after initial chemotherapy receive cyclophosphamide doxorubicin and vincristine as above Patients then undergo surgical resection or biopsy
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 100 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-20125A | None | None | None |
| EURO-INF-NB-STUDY-1999-991 | None | None | None |