Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006123
Status:
WITHDRAWN
Last Update Posted:
2018-05-16
First Post:
2000-08-03
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation Followed by Trastuzumab in Treating Women With Metastatic Breast Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy and peripheral stem cell transplantation followed by trastuzumab in treating women who have metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of chemotherapy and peripheral stem cell transplantation followed by trastuzumab in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the safety and toxicity profile specifically cardiac toxicity of trastuzumab Herceptin following high dose chemotherapy and autologous peripheral blood stem cell transplantation in women with metastatic breast cancer II Determine the time to disease progression and disease free survival in these patients when treated with this regimen III Determine the impact of trastuzumab Herceptin on minimal residual disease after autologous peripheral blood stem cell transplantation as evidenced by serial immunocytochemical analysis of bone marrow IV Determine the relationship between posttransplant reconstitution of antibody dependent cellular toxicity and the efficacy of trastuzumab Herceptin in these patients
OUTLINE This is a multicenter study Patients undergo stem cell mobilization with growth factors alone filgrastim G-CSF andor sargramostim GM-CSF or chemotherapy followed by growth factors depending on center Peripheral blood stem cells PBSC are then collected by leukapheresis Patients then receive high dose chemotherapy consisting of cyclophosphamide IV over 1 hour and cisplatin IV over 72 hours on days -6 to -4 and carmustine IV on day -3 or cyclophosphamide IV thiotepa IV and carboplatin IV over 96 hours on days -7 to -4 depending on center PBSC are reinfused on day 0 Patients then receive trastuzumab IV over 30-90 minutes weekly for 1 year or until disease progression beginning 5-8 weeks after PBSC reinfusion
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
OUTLINE This is a multicenter study Patients undergo stem cell mobilization with growth factors alone filgrastim G-CSF andor sargramostim GM-CSF or chemotherapy followed by growth factors depending on center Peripheral blood stem cells PBSC are then collected by leukapheresis Patients then receive high dose chemotherapy consisting of cyclophosphamide IV over 1 hour and cisplatin IV over 72 hours on days -6 to -4 and carmustine IV on day -3 or cyclophosphamide IV thiotepa IV and carboplatin IV over 96 hours on days -7 to -4 depending on center PBSC are reinfused on day 0 Patients then receive trastuzumab IV over 30-90 minutes weekly for 1 year or until disease progression beginning 5-8 weeks after PBSC reinfusion
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
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-V00-1610 | None | None | None |
| BIH-99-12 | None | None | None |
| BIH-W-99-0053-FB | None | None | None |