Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005576
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-05-02
Brief Title:
Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF CHIMERIC HUMANMURINE ANTI-GD2 MONOCLONAL ANTIBODY ch1418 WITH GM-CSF AND INTERLEUKIN-2 IL-2 IN CHILDREN WITH NEUROBLASTOMA IMMEDIATELY POST AUTOLOGOUS BMT OR PBSC RESCUE
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:
Monoclonal antibodies 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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of monoclonal antibody MOAB ch1418 when combined with sargramostim GM-CSF and interleukin-2 IL-2 after autologous bone marrow or peripheral blood stem cell rescue in children with neuroblastoma
II Determine the toxic effects of this regimen in these patients III Determine the pharmacokinetics including antibody level antibody-binding activity and presence of human anti-chimeric antibodies of this regimen in these patients
IV Determine the activity of IL-2 and MOAB ch1418 against tumor cells in terms of response using standard clinical measurements such as bone marrow immunocytology in these patients
V Determine the extent of coating of tumor cells bone marrow metastases by MOAB ch1418 in these patients
VI Determine the feasibility of isotretinoin administered between courses beginning after course 2 in these patients
OUTLINE This is a multicenter dose-escalation study of monoclonal antibody MOAB
Patients receive MOAB IV over 5 hours on days 7-10 during courses 2 and 4 and on days 3-6 during courses 1 3 and 5 sargramostim GM-CSF IV over 2 hours or subcutaneously daily on days 0-13 during courses 1 3 and 5 interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4 and oral isotretinoin twice daily on days 14-27 during courses 2 and 4 and on days 10-23 during courses 3 and 5 Treatment repeats every 24-32 days for 5 courses in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MOAB 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 A minimum of 6 additional patients are treated at the MTD
Patients are followed every other week for 2 months and then every 3 months for 6 months
PROJECTED ACCRUAL Approximately 6-16 patients will be accrued for this study within 1 year
I Determine the maximum tolerated dose of monoclonal antibody MOAB ch1418 when combined with sargramostim GM-CSF and interleukin-2 IL-2 after autologous bone marrow or peripheral blood stem cell rescue in children with neuroblastoma
II Determine the toxic effects of this regimen in these patients III Determine the pharmacokinetics including antibody level antibody-binding activity and presence of human anti-chimeric antibodies of this regimen in these patients
IV Determine the activity of IL-2 and MOAB ch1418 against tumor cells in terms of response using standard clinical measurements such as bone marrow immunocytology in these patients
V Determine the extent of coating of tumor cells bone marrow metastases by MOAB ch1418 in these patients
VI Determine the feasibility of isotretinoin administered between courses beginning after course 2 in these patients
OUTLINE This is a multicenter dose-escalation study of monoclonal antibody MOAB
Patients receive MOAB IV over 5 hours on days 7-10 during courses 2 and 4 and on days 3-6 during courses 1 3 and 5 sargramostim GM-CSF IV over 2 hours or subcutaneously daily on days 0-13 during courses 1 3 and 5 interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4 and oral isotretinoin twice daily on days 14-27 during courses 2 and 4 and on days 10-23 during courses 3 and 5 Treatment repeats every 24-32 days for 5 courses in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MOAB 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 A minimum of 6 additional patients are treated at the MTD
Patients are followed every other week for 2 months and then every 3 months for 6 months
PROJECTED ACCRUAL Approximately 6-16 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000063533 | REGISTRY | PDQ Physician Data Query | None |
| 0935 | None | None | None |