Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020176
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Allogeneic Breast Protocol 1 T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation after an immunoablative conditioning regimen to induce a state of mixed hostdonor chimerism in patients with metastatic breast cancer
Determine the ability of this treatment regimen to induce an allogeneic graft-versus-tumor response in these patients
Determine the feasibility of giving other approved therapies to these patients at the first sign of disease progression in order to stabilize or produce a minimal or partial response
OUTLINE Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4 Patients receive filgrastim G-CSF SC daily beginning on day 5 and continuing until blood counts recover Treatment repeats every 21 days for a maximum of 2 courses
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 beginning on day 22 of immune-depleting chemotherapy followed by allogeneic peripheral blood stem cell transplantation IV on day 0 Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40
Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42 70 and 98
Patients are followed twice weekly until day 100 and then at 6 9 12 18 and 24 months
PROJECTED ACCRUAL A maximum of 70 patients will be accrued for this study within 24 months
Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation after an immunoablative conditioning regimen to induce a state of mixed hostdonor chimerism in patients with metastatic breast cancer
Determine the ability of this treatment regimen to induce an allogeneic graft-versus-tumor response in these patients
Determine the feasibility of giving other approved therapies to these patients at the first sign of disease progression in order to stabilize or produce a minimal or partial response
OUTLINE Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4 Patients receive filgrastim G-CSF SC daily beginning on day 5 and continuing until blood counts recover Treatment repeats every 21 days for a maximum of 2 courses
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 beginning on day 22 of immune-depleting chemotherapy followed by allogeneic peripheral blood stem cell transplantation IV on day 0 Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40
Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42 70 and 98
Patients are followed twice weekly until day 100 and then at 6 9 12 18 and 24 months
PROJECTED ACCRUAL A maximum of 70 patients will be accrued for this study within 24 months
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-00-C-0119 | None | None | None |
| NCI-1027 | None | None | None |