Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025649
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation 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 2 3 4 and 4S MYCN Amplified Tumors
Status:
COMPLETED
Status Verified Date:
2001-12
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 chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma
Detailed Description:
OBJECTIVES
Determine the survival of infants with newly diagnosed stage II III IV or IVS neuroblastoma with MYCN amplification treated with etoposide carboplatin cyclophosphamide doxorubicin and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation
Determine whether there are 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 then 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
Patients receive filgrastim G-CSF subcutaneously daily for 5 days Patients undergo leukapheresis to collect peripheral blood stem cells PBSC Patients who do not mobilize sufficient cells undergo bone marrow harvest
Patients eligible for surgery undergo surgical resection Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study
Beginning within 2 weeks after surgery patients receive 1 additional course of VP-CARBO chemotherapy followed by 1 additional course of CADO chemotherapy
After at least 3 weeks patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2 PBSC or bone marrow are reinfused on day 0
At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation patients undergo radiotherapy to the primary site according to preoperative imaging studies Patients are treated with oral tretinoin after megatherapy
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
Determine the survival of infants with newly diagnosed stage II III IV or IVS neuroblastoma with MYCN amplification treated with etoposide carboplatin cyclophosphamide doxorubicin and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation
Determine whether there are 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 then 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
Patients receive filgrastim G-CSF subcutaneously daily for 5 days Patients undergo leukapheresis to collect peripheral blood stem cells PBSC Patients who do not mobilize sufficient cells undergo bone marrow harvest
Patients eligible for surgery undergo surgical resection Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study
Beginning within 2 weeks after surgery patients receive 1 additional course of VP-CARBO chemotherapy followed by 1 additional course of CADO chemotherapy
After at least 3 weeks patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2 PBSC or bone marrow are reinfused on day 0
At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation patients undergo radiotherapy to the primary site according to preoperative imaging studies Patients are treated with oral tretinoin after megatherapy
Patients are followed within 6 months and then annually for 5 years
PROJECTED ACCRUAL A total of 40 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-20125D | None | None | None |
| EURO-INF-NB-STUDY-1999-994 | None | None | None |