Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006261
Status:
WITHDRAWN
Last Update Posted:
2010-06-10
First Post:
2000-09-11
Brief Title:
Allogeneic Transplantation Using Mini-Conditioning for Treatment of Stage IV Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Allogeneic Transplantation Using Mini-Conditioning for Treatment of Stage IV Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2010-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy Donor lymphocytes may attack and destroy cancer cells
PURPOSE This phase II trial is studying the effectiveness of combination chemotherapy peripheral stem cell transplantation and donor lymphocyte infusion in treating women with stage IV breast cancer
PURPOSE This phase II trial is studying the effectiveness of combination chemotherapy peripheral stem cell transplantation and donor lymphocyte infusion in treating women with stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the tumor response in women with stage IV breast cancer who achieve partial remission after a mini-conditioning regimen comprising fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation PBSCT and donor lymphocyte infusion DLI II Determine the progression free survival in patients who achieve complete remission after this treatment regimen III Determine whether DLI exerts graft versus tumor effect in these patients IV Determine the acute and delayed toxicities of this regimen in these patients V Determine the rates of durable hematologic engraftment in patients treated with this regimen VI Determine the incidence and severity of acute and chronic graft versus host disease in patients treated with this regimen VII Determine the extent of chimerism in patients treated with this nonmyeloablative conditioning regimen VIII Determine the rate and quality of immune reconstitution in patients treated with this regimen IX Determine the event free and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive salvage chemotherapy comprised of docetaxel IV over 1 hour and doxorubicin IV over several minutes on day 1 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning within 4-10 weeks after completion of salvage chemotherapy patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2 Patients then receive filgrastim G-CSF and sargramostim GM-CSF mobilized allogeneic peripheral blood stem cells PBSC IV on day 0 Beginning on day 120 after PBSC transplantation eligible patients receive unmobilized donor lymphocyte infusion DLI over 15-30 minutes Treatment continues monthly for a total of 3 DLIs in the absence of grade III or IV graft versus host disease or marrow aplasia Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive salvage chemotherapy comprised of docetaxel IV over 1 hour and doxorubicin IV over several minutes on day 1 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning within 4-10 weeks after completion of salvage chemotherapy patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2 Patients then receive filgrastim G-CSF and sargramostim GM-CSF mobilized allogeneic peripheral blood stem cells PBSC IV on day 0 Beginning on day 120 after PBSC transplantation eligible patients receive unmobilized donor lymphocyte infusion DLI over 15-30 minutes Treatment continues monthly for a total of 3 DLIs in the absence of grade III or IV graft versus host disease or marrow aplasia Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30-50 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CWRU-1199 | OTHER | None | None |
| NCI-G00-1855 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |