Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089258
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2004-08-04
Brief Title:
Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
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 Biologic Response Modifiers for High-risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 Beta-glucan isotretinoin and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody Combining different types of biological therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving beta-glucan isotretinoin and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment
PURPOSE This phase II trial is studying how well giving beta-glucan isotretinoin and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the efficacy of beta-glucan isotretinoin and sargramostim GM-CSF in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma
Determine the antitumor activity of this regimen in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study Patients are stratified according to refractory disease primary refractory never had disease progression or disease recurrence vs secondary refractory recurrent disease that did not respond completely to reinduction therapy
Courses 1 and 2 Patients receive sargramostim GM-CSF subcutaneously once daily on days -5 to 11 Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody MOAB 3F8 IV over 30-90 minutes on days 0-4 and 7-11
Courses 3 and 4 Patients receive GM-CSF beta-glucan and MOAB 3F8 as above Patients also receive oral isotretinoin twice daily on days -2 to 11
Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 27-74 patients 10-33 for stratum 1 and 17-41 for stratum 2 will be accrued for this study
Determine the efficacy of beta-glucan isotretinoin and sargramostim GM-CSF in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma
Determine the antitumor activity of this regimen in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study Patients are stratified according to refractory disease primary refractory never had disease progression or disease recurrence vs secondary refractory recurrent disease that did not respond completely to reinduction therapy
Courses 1 and 2 Patients receive sargramostim GM-CSF subcutaneously once daily on days -5 to 11 Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody MOAB 3F8 IV over 30-90 minutes on days 0-4 and 7-11
Courses 3 and 4 Patients receive GM-CSF beta-glucan and MOAB 3F8 as above Patients also receive oral isotretinoin twice daily on days -2 to 11
Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 27-74 patients 10-33 for stratum 1 and 17-41 for stratum 2 will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-04050 | None | None | None |