Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007891
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2001-01-06
Brief Title:
Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
Sponsor:
Cancer Research Institute of Contra Costa
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2004-09
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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 labeled humanized monoclonal antibody BrE-3 when given in combination with indium In 111 labeled humanized monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem cell transplantation in patients with metastatic breast cancer
Determine hematopoietic engraftment in these patients treated with this regimen
Determine the ability of indium In 111 labeled humanized monoclonal antibody BrE-3 to image metastatic disease in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the preliminary antitumor response in these patients treated with this regimen
OUTLINE This is a dose escalation study of yttrium Y 90 labeled humanized monoclonal antibody BrE-3 Y90 huMOAB BrE-3
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled humanized monoclonal antibody BrE-3 IV over 1-2 hours on day -14 Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0 Patients also receive filgrastim G-CSF IV beginning on day 0 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities
Patients are followed every 3-4 months for 1 year and then at least annually thereafter
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of yttrium Y 90 labeled humanized monoclonal antibody BrE-3 when given in combination with indium In 111 labeled humanized monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem cell transplantation in patients with metastatic breast cancer
Determine hematopoietic engraftment in these patients treated with this regimen
Determine the ability of indium In 111 labeled humanized monoclonal antibody BrE-3 to image metastatic disease in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the preliminary antitumor response in these patients treated with this regimen
OUTLINE This is a dose escalation study of yttrium Y 90 labeled humanized monoclonal antibody BrE-3 Y90 huMOAB BrE-3
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled humanized monoclonal antibody BrE-3 IV over 1-2 hours on day -14 Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0 Patients also receive filgrastim G-CSF IV beginning on day 0 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities
Patients are followed every 3-4 months for 1 year and then at least annually thereafter
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study
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-V00-1637 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068340 | REGISTRY | None | None |
| UCHSC-97467 | None | None | None |