Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004110
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
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 can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma
Detailed Description:
OBJECTIVES
Determine the antitumor effects of monoclonal antibody 3F8 etoposide and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma
Assess progression-free survival in these patients after this treatment
Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients
OUTLINE Patients are stratified according to disease status evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease
Patients receive monoclonal antibody 3F8 MOAB 3F8 IV over 15 hours once daily on days 1-10 and oral etoposide once daily on days 29-49 Treatment repeats every 8 weeks for 4 courses in the absence of disease progression human anti-mouse antibody HAMA response or unacceptable toxicity
If HAMA fails to develop after completion of 4 courses of MOAB 3F8 patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1000 UmL or until month 24 whichever occurs first
Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest Treatment repeats for a total of 6 courses
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study within 5 years
Determine the antitumor effects of monoclonal antibody 3F8 etoposide and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma
Assess progression-free survival in these patients after this treatment
Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients
OUTLINE Patients are stratified according to disease status evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease
Patients receive monoclonal antibody 3F8 MOAB 3F8 IV over 15 hours once daily on days 1-10 and oral etoposide once daily on days 29-49 Treatment repeats every 8 weeks for 4 courses in the absence of disease progression human anti-mouse antibody HAMA response or unacceptable toxicity
If HAMA fails to develop after completion of 4 courses of MOAB 3F8 patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1000 UmL or until month 24 whichever occurs first
Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest Treatment repeats for a total of 6 courses
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study within 5 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-G99-1599 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067333 | REGISTRY | None | None |