Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002634
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Chemotherapy Radiation Therapy Immunotherapy and Bone Marrow Transplantation in Treating Patients With Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
N7 EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA
Status:
COMPLETED
Status Verified Date:
2013-07
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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy radiation therapy immunotherapy and bone marrow transplantation in treating patients with neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy radiation therapy immunotherapy and bone marrow transplantation in treating patients with neuroblastoma
Detailed Description:
OBJECTIVES I Improve the complete remission rate and progression-free survival and reduce the relapse rate of patients with poor-risk neuroblastoma using intensive multimodality therapy cyclophosphamidedoxorubicinvincristine and cisplatinetoposide external-beam radiotherapy and surgery when feasible followed by radioimmunotherapy with iodine I 131 labeled monoclonal antibody 3F8 followed by autologous bone marrow transplant and immunotherapy with unlabeled 3F8 II Identify biologic and clinical prognostic factors that may guide future modifications in treatment approaches for this malignancy
OUTLINE Patients are stratified by prior therapy yes vs no Patients undergo surgery either at diagnosis or after at least 4 courses of chemotherapy then possibly again after completion of chemotherapy Patients receive cyclophosphamide IV over 6 hours on days 1-2 and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1 2 4 and 6 Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are administered as courses 3 5 and 7 Courses are administered every 16-21 days Autologous bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for tumor cells Patients undergo radiotherapy after the completion of chemotherapy Radiotherapy is administered twice a day for 7 days Patients then receive iodine I 131 labeled monoclonal antibody 3F8 MOAB 3F8 on day -5 and again on days 1-5 Autologous bone marrow is reinfused on day 5 and filgrastim G-CSF is administered IV or subcutaneously beginning day 6 Patients who do not develop HAMA or an allergy to mouse proteins receive unlabeled MOAB 3F8 IV over 15 hours 5 days a week for 2 weeks Treatment repeats every 1-2 months for up to 4 courses Patients are followed every month for 2 years every 3 months for 1 year then annually thereafter
PROJECTED ACCRUAL Up to 45 newly diagnosed patients will be accrued for this study within 5 years
OUTLINE Patients are stratified by prior therapy yes vs no Patients undergo surgery either at diagnosis or after at least 4 courses of chemotherapy then possibly again after completion of chemotherapy Patients receive cyclophosphamide IV over 6 hours on days 1-2 and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1 2 4 and 6 Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are administered as courses 3 5 and 7 Courses are administered every 16-21 days Autologous bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for tumor cells Patients undergo radiotherapy after the completion of chemotherapy Radiotherapy is administered twice a day for 7 days Patients then receive iodine I 131 labeled monoclonal antibody 3F8 MOAB 3F8 on day -5 and again on days 1-5 Autologous bone marrow is reinfused on day 5 and filgrastim G-CSF is administered IV or subcutaneously beginning day 6 Patients who do not develop HAMA or an allergy to mouse proteins receive unlabeled MOAB 3F8 IV over 15 hours 5 days a week for 2 weeks Treatment repeats every 1-2 months for up to 4 courses Patients are followed every month for 2 years every 3 months for 1 year then annually thereafter
PROJECTED ACCRUAL Up to 45 newly diagnosed patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V95-0622 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064084 | REGISTRY | None | None |
| MSKCC-FDR001041 | None | None | None |