Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450827
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2007-03-20
Brief Title:
Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Combination of Targeted I -3F8-Mediated Radioimmunotherapy and Bevacizumab in Patients With Relapsed or Refractory Neuroblastoma A Phase I Study
Status:
COMPLETED
Status Verified Date:
2015-09
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 iodine I 131 monoclonal antibody 3F8 and bevacizumab 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 Bevacizumab may also stop the growth of neuroblastoma by blocking blood flow to the tumor Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity of iodine I 131 monoclonal antibody 3F8 131I-3F8 and bevacizumab in patients with relapsed or refractory neuroblastoma
Determine the hematopoietic recovery after autologous stem cell rescue in patients treated with this regimen
Secondary
Determine the clinical response rates in patients treated with this regimen
Assess whole body dosimetry for 131I-3F8
Assess tumor targeting of 131I-3F8 before and after bevacizumab
OUTLINE This is a dose-escalation study of iodine I 131 monoclonal antibody 3F8 131I-3F8
Patients receive 131I-3F8 IV over 20-30 minutes on day 0 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 4 courses Patients whose blood counts do not recover and whose human antimouse antibody HAMA titer 1000 UmL after course 1 receive one dose of 131I-3F8 alone followed by autologous stem cell rescue ASCR and filgrastim G-CSF Patients whose blood counts do not recover and whose HAMA titer 1000 UmL after course 1 undergo ASCR followed by G-CSF Patients whose blood counts recover and whose HAMA titer 1000 UmL after course 1 receive 3 more courses of 131I-3F8 and bevacizumab in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of 131I-3F8 and bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed at 3-4 weeks and then every 3-6 months thereafter
Primary
Determine the toxicity of iodine I 131 monoclonal antibody 3F8 131I-3F8 and bevacizumab in patients with relapsed or refractory neuroblastoma
Determine the hematopoietic recovery after autologous stem cell rescue in patients treated with this regimen
Secondary
Determine the clinical response rates in patients treated with this regimen
Assess whole body dosimetry for 131I-3F8
Assess tumor targeting of 131I-3F8 before and after bevacizumab
OUTLINE This is a dose-escalation study of iodine I 131 monoclonal antibody 3F8 131I-3F8
Patients receive 131I-3F8 IV over 20-30 minutes on day 0 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 4 courses Patients whose blood counts do not recover and whose human antimouse antibody HAMA titer 1000 UmL after course 1 receive one dose of 131I-3F8 alone followed by autologous stem cell rescue ASCR and filgrastim G-CSF Patients whose blood counts do not recover and whose HAMA titer 1000 UmL after course 1 undergo ASCR followed by G-CSF Patients whose blood counts recover and whose HAMA titer 1000 UmL after course 1 receive 3 more courses of 131I-3F8 and bevacizumab in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of 131I-3F8 and bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed at 3-4 weeks and then every 3-6 months thereafter
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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-06072 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |