Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003086
Status:
TERMINATED
Last Update Posted:
2020-07-14
First Post:
1999-11-01
Brief Title:
Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Louisiana State University Health Sciences Center Shreveport
Study Overview
Official Title:
Phase III Study of Samarium 153 as Part of a Double Sequential Autologous Bone Marrow Transplant ABMT for Patients With Stage IV Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no participants enrolled in a three year period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer
PURPOSE Phase III trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer II Determine the response rate median duration of response and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support
OUTLINE This is a dose escalation study Patients are first treated with salvage chemotherapy for no more than 4 cycles At least a partial remission must be achieved Peripheral blood stem cells PBSC are collected following the administration of filgrastim granulocyte colony-stimulating factor G-CSF After recovery from the prior chemotherapy high dose chemotherapy begins Paclitaxel is administered as a 24 hour infusion on day -7 Melphalan IV is administered over 1 hour on days -6 and -5 PBSC are infused on day 0 A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy Samarium 153 is administered on day -14 Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients Cyclophosphamide thiotepa and carboplatin are infused over 24 hours on days -7 through -4 PBSC are infused on day 0 followed by G-CSF IV The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study Patients are followed until death
PROJECTED ACCRUAL At least 12 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients are first treated with salvage chemotherapy for no more than 4 cycles At least a partial remission must be achieved Peripheral blood stem cells PBSC are collected following the administration of filgrastim granulocyte colony-stimulating factor G-CSF After recovery from the prior chemotherapy high dose chemotherapy begins Paclitaxel is administered as a 24 hour infusion on day -7 Melphalan IV is administered over 1 hour on days -6 and -5 PBSC are infused on day 0 A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy Samarium 153 is administered on day -14 Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients Cyclophosphamide thiotepa and carboplatin are infused over 24 hours on days -7 through -4 PBSC are infused on day 0 followed by G-CSF IV The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study Patients are followed until death
PROJECTED ACCRUAL At least 12 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-V97-1341 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065786 | REGISTRY | None | None |