Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006032
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Intensive-Dose Topotecan IfosfamideMesna and Etoposide TIME Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by autologous peripheral stem cell transplantation in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by autologous peripheral stem cell transplantation in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic breast cancer II Evaluate the response rates progression free survival engraftment and nonrelapse related mortality in women treated with this regimen III Evaluate the pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of ifosfamide and etoposide in these women
OUTLINE Peripheral blood stem cells PBSC are harvested from the patient and stored Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to -6 and etoposide IV daily over 24 hours on days -5 to -3 Autologous PBSC are reinfused on day 0 Patients are followed at 1 3 6 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study over 2 years
OUTLINE Peripheral blood stem cells PBSC are harvested from the patient and stored Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to -6 and etoposide IV daily over 24 hours on days -5 to -3 Autologous PBSC are reinfused on day 0 Patients are followed at 1 3 6 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study over 2 years
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-G00-1809 | None | None | None |
| MCC-12220 | None | None | None |
| MCC-IRB-5699 | None | None | None |