Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020410
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2003-09
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 Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by autologous peripheral blood stem cell transplantation in patients with relapsed or metastatic breast cancer
Determine the toxicity of this treatment regimen in these patients
Determine the clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 Y90 MOAB B3
Patients receive filgrastim G-CSF subcutaneously SC daily beginning 4 days prior to peripheral blood stem cell PBSC collection and continuing until the target number of cells is reached
After PBSC collection patients receive indium In 111 monoclonal antibody B3 IV over 30-60 minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60 minutes on day 0 After at least day 7 patients undergo autologous PBSC reinfusion Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 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 are followed at 1 week 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 24-36 months
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by autologous peripheral blood stem cell transplantation in patients with relapsed or metastatic breast cancer
Determine the toxicity of this treatment regimen in these patients
Determine the clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 Y90 MOAB B3
Patients receive filgrastim G-CSF subcutaneously SC daily beginning 4 days prior to peripheral blood stem cell PBSC collection and continuing until the target number of cells is reached
After PBSC collection patients receive indium In 111 monoclonal antibody B3 IV over 30-60 minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60 minutes on day 0 After at least day 7 patients undergo autologous PBSC reinfusion Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 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 are followed at 1 week 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 24-36 months
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-213 | None | None | None |
| NCI-00-C-0206 | None | None | None |