Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182793
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-09-15
Brief Title:
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin Thiotepa and Cyclophosphamide STMP V Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIBC Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of tandem high-dose chemotherapy comprising melphalan carboplatin thiotepa and cyclophosphamide with or without trastuzumab Herceptin followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB IIIC or IV breast cancer
Determine the toxic effects of this regimen in these patients
OUTLINE Patients undergo stem cell collection
Course 1 Patients receive high-dose melphalan IV with or without trastuzumab Herceptin One day later patients undergo autologous peripheral blood stem cell PBSC transplantation No more than 7 weeks later patients proceed to course 2
Course 2 Patients receive high-dose carboplatin thiotepa and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation
After recover from high-dose chemotherapy and autologous PBSC transplantation patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Determine the feasibility of tandem high-dose chemotherapy comprising melphalan carboplatin thiotepa and cyclophosphamide with or without trastuzumab Herceptin followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB IIIC or IV breast cancer
Determine the toxic effects of this regimen in these patients
OUTLINE Patients undergo stem cell collection
Course 1 Patients receive high-dose melphalan IV with or without trastuzumab Herceptin One day later patients undergo autologous peripheral blood stem cell PBSC transplantation No more than 7 weeks later patients proceed to course 2
Course 2 Patients receive high-dose carboplatin thiotepa and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation
After recover from high-dose chemotherapy and autologous PBSC transplantation patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites
PROJECTED ACCRUAL A total of 100 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 |
|---|---|---|---|
| CDR0000442105 | REGISTRY | PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |