Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002560
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR GM-CSF FOR NEUROBLASTOMA
Status:
COMPLETED
Status Verified Date:
2013-06
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 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining colony-stimulating factors such as sargramostim with monoclonal antibodies may be an effective treatment for advanced neuroblastoma
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma
Detailed Description:
OBJECTIVES
Define the antitumor effects of monoclonal antibody 3F8sargramostim 3F8GM-CSF in patients with advanced neuroblastoma
Assess the biological effects of 3F8GM-CSF in these patients
OUTLINE Patients receive monoclonal antibody 3F8 IV over 15 hours on days 0-4 and 7-11 and sargramostim GM-CSF IV over 2 hours on days -5 to 11 Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease HAMA response or unacceptable toxicity
PROJECTED ACCRUAL A total of 11-40 patients will be accrued for this study over 4 years
Define the antitumor effects of monoclonal antibody 3F8sargramostim 3F8GM-CSF in patients with advanced neuroblastoma
Assess the biological effects of 3F8GM-CSF in these patients
OUTLINE Patients receive monoclonal antibody 3F8 IV over 15 hours on days 0-4 and 7-11 and sargramostim GM-CSF IV over 2 hours on days -5 to 11 Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease HAMA response or unacceptable toxicity
PROJECTED ACCRUAL A total of 11-40 patients will be accrued for this study over 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 |
|---|---|---|---|
| NCI-V94-0416 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063466 | REGISTRY | None | None |