Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003877
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation With or Without Stromagen Following Chemotherapy in Treating Women With Metastatic Breast Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Study in Metastatic Breast Cancer Patients Infused With Stromagen and Isolated Mobilized Autologous Peripheral Blood CD34 Progenitor Cells After High-Dose Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-03
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 Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells It is not yet known whether Stromagen improves the success of stem cell transplantation in women with breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of Stromagen during stem cell transplantation following chemotherapy in treating women with metastatic breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of Stromagen during stem cell transplantation following chemotherapy in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the safety of expanded mesenchymal stem cells Stromagen infusion and autologous CD34 peripheral blood stem cells transplantation after high dose chemotherapy in women with metastatic breast cancer II Compare the time to neutrophil and platelet engraftment in patients receiving different doses of Stromagen III Evaluate the immune reconstitution of these patients after this therapy
OUTLINE This is a randomized placebo controlled blinded study Patients are randomly assigned to one of three treatment arms All patients undergo mobilization of peripheral blood stem cells PBSC using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1 and filgrastim G-CSF subcutaneously beginning on day 4 and continuing until completion of leukapheresis PBSC and bone marrow cells are collected and CD34 positive cells are then selected About 4 weeks later patients receive high dose chemotherapy Cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours are administered on days -7 to -4 Patients then receive placebo or one of two doses of expanded mesenchymal stem cells Stromagen IV on day -1 and CD34 selected PBSC IV over 2 hours on day 0 Patients are followed at 6 weeks and 12 weeks than at 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is a randomized placebo controlled blinded study Patients are randomly assigned to one of three treatment arms All patients undergo mobilization of peripheral blood stem cells PBSC using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1 and filgrastim G-CSF subcutaneously beginning on day 4 and continuing until completion of leukapheresis PBSC and bone marrow cells are collected and CD34 positive cells are then selected About 4 weeks later patients receive high dose chemotherapy Cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours are administered on days -7 to -4 Patients then receive placebo or one of two doses of expanded mesenchymal stem cells Stromagen IV on day -1 and CD34 selected PBSC IV over 2 hours on day 0 Patients are followed at 6 weeks and 12 weeks than at 1 year
PROJECTED ACCRUAL A total of 30 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-G99-1516 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |
| RPCI-DS-9828 | None | None | None |
| CWRU-OSIR-1198 | None | None | None |
| OSIRIS-101 | None | None | None |