Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072358
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2003-11-04
Brief Title:
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2022-04
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 Monoclonal antibodies such as monoclonal antibody 3F8 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma
Detailed Description:
OBJECTIVES
Determine the efficacy of sargramostim GM-CSF in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma
Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen
Compare the effects of short-term 2-hour intravenous vs prolonged subcutaneous release daily GM-CSF on granulocyte activation in order to establish the optimal route for tumor-cell kill in these patients
OUTLINE This is an open-label study Patients are stratified according to evaluable disease yes primary refractory bone marrow disease vs no no evidence of disease
Patients receive sargramostim GM-CSF subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 05-15 hours on days 0-4 Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity
Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8 patients also receive oral isotretinoin twice daily on days 1-14 when no monoclonal antibody 3F8 is administered Treatment with isotretinoin repeats approximately every 28 days for 6 courses
PROJECTED ACCRUAL A total of 340 patients will be accrued for this study
Determine the efficacy of sargramostim GM-CSF in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma
Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen
Compare the effects of short-term 2-hour intravenous vs prolonged subcutaneous release daily GM-CSF on granulocyte activation in order to establish the optimal route for tumor-cell kill in these patients
OUTLINE This is an open-label study Patients are stratified according to evaluable disease yes primary refractory bone marrow disease vs no no evidence of disease
Patients receive sargramostim GM-CSF subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 05-15 hours on days 0-4 Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity
Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8 patients also receive oral isotretinoin twice daily on days 1-14 when no monoclonal antibody 3F8 is administered Treatment with isotretinoin repeats approximately every 28 days for 6 courses
PROJECTED ACCRUAL A total of 340 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-03077 | None | None | None |