Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450307
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2007-03-20
Brief Title:
Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk Refractory or Relapsed Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma A Phase I Trial
Status:
COMPLETED
Status Verified Date:
2013-10
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 3F8 can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of monoclonal antibody 3F8 when given together with GM-CSF in treating young patients with high-risk refractory or relapsed neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of monoclonal antibody 3F8 when given together with GM-CSF in treating young patients with high-risk refractory or relapsed neuroblastoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with sargramostim GM-CSF in young patients with high-risk refractory or relapsed neuroblastoma
Assess anti-neuroblastoma effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of monoclonal antibody 3F8
Patients receive sargramostim GM-CSF subcutaneously once daily on days -5 to 11 and monoclonal antibody 3F8 IV over 30 minutes on days 0-4 and 7-11 Treatment repeats every 4-6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody 3F8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months for 2 years
Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with sargramostim GM-CSF in young patients with high-risk refractory or relapsed neuroblastoma
Assess anti-neuroblastoma effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of monoclonal antibody 3F8
Patients receive sargramostim GM-CSF subcutaneously once daily on days -5 to 11 and monoclonal antibody 3F8 IV over 30 minutes on days 0-4 and 7-11 Treatment repeats every 4-6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody 3F8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months for 2 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 |
|---|---|---|---|
| MSKCC-05015 | None | None | None |