Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037011
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2002-05-13
Brief Title:
Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic 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 Biological therapies such as beta-glucan use different ways to stimulate the immune system and stop cancer cells from growing Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining beta-glucan and monoclonal antibody may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastatic neuroblastoma
PURPOSE Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastatic neuroblastoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in patients with metastatic neuroblastoma
Determine the toxicity of this regimen in these patients
Assess the biological effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral beta-glucan and monoclonal antibody 3F8 MOAB 3F8 IV within 15 hours on days 1-5 and 8-12 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months every 2 months for 6 months and then every 3-6 months for 2 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in patients with metastatic neuroblastoma
Determine the toxicity of this regimen in these patients
Assess the biological effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral beta-glucan and monoclonal antibody 3F8 MOAB 3F8 IV within 15 hours on days 1-5 and 8-12 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months every 2 months for 6 months and then every 3-6 months for 2 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 2 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-G02-2067 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-01075 | None | None | None |