Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005798
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With 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 Cyclophosphamide Thiotepa and Carboplatin CTC as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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:
CTC
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 peripheral stem cell transplantation in treating women who have breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer
Detailed Description:
OBJECTIVES I Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide thiotepa and carboplatin followed by autologous hematopoietic stem cell transplantation II Determine the safety and efficacy of this combination chemotherapy regimen in this patient population
OUTLINE Peripheral blood stem cells PBSC are collected Patients sequentially receive cyclophosphamide IV over 1 hour thiotepa IV over 1 hour and carboplatin IV over 1 hour on days -6 to -4 PBSC are reinfused on day 0 Patients are followed at 3 months 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study
OUTLINE Peripheral blood stem cells PBSC are collected Patients sequentially receive cyclophosphamide IV over 1 hour thiotepa IV over 1 hour and carboplatin IV over 1 hour on days -6 to -4 PBSC are reinfused on day 0 Patients are followed at 3 months 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes 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-G00-1760 | OTHER | NCI | None |
| IRB-3898 | OTHER | None | None |