Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004085
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
1999-12-10
Brief Title:
Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Organization:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Study Overview
Official Title:
Phase III Trial of High-Dose Radioimmunotherapy With a 90Y-Humanized MN-14 Anti-Carcinoembryonic Antigen CEA Antibody for the Treatment of Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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 deliver tumor-killing substances to them Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose-limiting toxicity of yttrium Y 90 monoclonal antibody MN-14 Y90 MOAB MN-14 plus peripheral blood stem cell rescue in patients with stage IV breast cancer II Determine the pharmacokinetic profile of Y90 MOAB MN-14 in the blood normal organs and tumors of this patient population III Determine the antibody response to Y90 MOAB MN-14 in these patients IV Determine the antitumor effect of this regimen in these patients V Determine the radiation absorbed dose to normal organs and tumors
OUTLINE This is a dose-escalation multicenter study Patients receive filgrastim G-CSF subcutaneously SC with or without chemotherapy on days -28 to -14 and peripheral blood stem cell PBSC collection on days -14 to -11 If an adequate number of CD34 cells are not harvested bone marrow may be collected Patients receive pretherapy imaging with indium In 111 monoclonal antibody MN-14 IV for up to 40 minutes on day -7 followed by whole body imaging on days -7 to 0 Patients receive yttrium Y 90 monoclonal antibody MN-14 Y90 MOAB MN-14 IV for up to 40 minutes on day 0 PBSC or bone marrow is reinfused on days 6 to 14 depending on antibody clearance Patients receive G-CSF SC or IV until blood counts recover Cohorts of 3-6 patients receive escalating doses of Y90 MOAB MN-14 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 Patients are followed weekly for 2 months monthly for 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 25 years
OUTLINE This is a dose-escalation multicenter study Patients receive filgrastim G-CSF subcutaneously SC with or without chemotherapy on days -28 to -14 and peripheral blood stem cell PBSC collection on days -14 to -11 If an adequate number of CD34 cells are not harvested bone marrow may be collected Patients receive pretherapy imaging with indium In 111 monoclonal antibody MN-14 IV for up to 40 minutes on day -7 followed by whole body imaging on days -7 to 0 Patients receive yttrium Y 90 monoclonal antibody MN-14 Y90 MOAB MN-14 IV for up to 40 minutes on day 0 PBSC or bone marrow is reinfused on days 6 to 14 depending on antibody clearance Patients receive G-CSF SC or IV until blood counts recover Cohorts of 3-6 patients receive escalating doses of Y90 MOAB MN-14 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 Patients are followed weekly for 2 months monthly for 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| NCI-V99-1568 | US NIH GrantContract | None | httpsreporternihgovquickSearchR35CA039841 |
| R35CA039841 | NIH | None | None |
| CMMI-C-041A-98 | None | None | None |
| NCI-H99-0039 | None | None | None |