Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492167
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2007-06-25
Brief Title:
Beta-Glucan and Monoclonal Antibody 3F8 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 Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2022-03
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 Beta-glucan may stimulate the immune system and stop tumor cells from growing 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 Giving beta-glucan together with monoclonal antibody 3F8 may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of beta-glucan when given together with monoclonal antibody 3F8 in treating patients with metastatic neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of beta-glucan when given together with monoclonal antibody 3F8 in treating patients with metastatic neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical toxicity of beta-glucan in combination with monoclonal antibody 3F8 in patients with metastatic neuroblastoma
Evaluate the biologic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of beta-glucan
Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV over 30-90 minutes on days 1-5 and 8-12 Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity and with a human antimouse antibody HAMA titer 1000 UmL
Cohorts of 3-6 patients receive escalating doses of beta-glucan 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
Patients undergo urine bone marrow and blood sample collection periodically for biological studies Samples are analyzed for antibody-dependent cellular cytotoxicity complement-mediated cytotoxicity and serum HAMA response via immunohistochemistry
After completion of study treatment patients are followed periodically
Primary
Determine the clinical toxicity of beta-glucan in combination with monoclonal antibody 3F8 in patients with metastatic neuroblastoma
Evaluate the biologic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of beta-glucan
Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV over 30-90 minutes on days 1-5 and 8-12 Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity and with a human antimouse antibody HAMA titer 1000 UmL
Cohorts of 3-6 patients receive escalating doses of beta-glucan 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
Patients undergo urine bone marrow and blood sample collection periodically for biological studies Samples are analyzed for antibody-dependent cellular cytotoxicity complement-mediated cytotoxicity and serum HAMA response via immunohistochemistry
After completion of study treatment patients are followed periodically
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-05073 | None | None | None |