Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020722
Status:
TERMINATED
Last Update Posted:
2016-02-17
First Post:
2001-07-11
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant Pilot Phase II
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding to continue study
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 plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase II trial is studying how well chemotherapy followed by peripheral stem cell transplantation plus biological therapy works in treating women with stage IV breast cancer
PURPOSE This phase II trial is studying how well chemotherapy followed by peripheral stem cell transplantation plus biological therapy works in treating women with stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine whether the use of autologous peripheral blood stem cell transplantation followed by immunotherapy with activated T cells in women with stage IV breast cancer improves progression-free survival PFS compared to a reported mean PFS in patients treated with second-line chemotherapy with matching inclusion criteria by published trials
Determine if this regimen improves clinical response and overall survival
Perform sequential immune monitoring studies including phenotyping cytotoxic assays EliSpots for IFNγ selected T-cell repertoire Vβ analysis HER2new tetramer analysis and serum tumor markers
Test correlations between immune function tests and clinical endpoints
OUTLINE Patients are stratified according to tumor classification chemosensitive vs chemoresistant
Patients receive filgrastim G-CSF subcutaneously SC daily for 4 days followed by peripheral blood mononuclear cell PBMC collection for PBSCT and generation of activated T cells ATC The PBMC are treated ex vivo with monoclonal antibody OKT3 to form ATC The ATC are expanded for 12-14 days in interleukin-2 IL-2
Patients then receive high-dose chemotherapy Patients with chemosensitive disease receive cyclophosphamide IV over 1 hour thiotepa IV over 1 hour and carboplatin IV over 1 hour on days -4 -3 and -2 Patients with chemoresistant disease receive ifosfamide IV over 1 hour etoposide IV twice daily and carboplatin IV over 1 hour on days -8 to -3 Patients undergo autologous PBSC transplantation on day 0 or on both day 0 and day 1
Patients then receive ATC IV over 15-20 minutes three times per week starting approximately on day 1 for three weeks and then once weekly for at least 6 doses
After completion of study therapy patients are followed periodically for up to 2 years after PBSC
Determine whether the use of autologous peripheral blood stem cell transplantation followed by immunotherapy with activated T cells in women with stage IV breast cancer improves progression-free survival PFS compared to a reported mean PFS in patients treated with second-line chemotherapy with matching inclusion criteria by published trials
Determine if this regimen improves clinical response and overall survival
Perform sequential immune monitoring studies including phenotyping cytotoxic assays EliSpots for IFNγ selected T-cell repertoire Vβ analysis HER2new tetramer analysis and serum tumor markers
Test correlations between immune function tests and clinical endpoints
OUTLINE Patients are stratified according to tumor classification chemosensitive vs chemoresistant
Patients receive filgrastim G-CSF subcutaneously SC daily for 4 days followed by peripheral blood mononuclear cell PBMC collection for PBSCT and generation of activated T cells ATC The PBMC are treated ex vivo with monoclonal antibody OKT3 to form ATC The ATC are expanded for 12-14 days in interleukin-2 IL-2
Patients then receive high-dose chemotherapy Patients with chemosensitive disease receive cyclophosphamide IV over 1 hour thiotepa IV over 1 hour and carboplatin IV over 1 hour on days -4 -3 and -2 Patients with chemoresistant disease receive ifosfamide IV over 1 hour etoposide IV twice daily and carboplatin IV over 1 hour on days -8 to -3 Patients undergo autologous PBSC transplantation on day 0 or on both day 0 and day 1
Patients then receive ATC IV over 15-20 minutes three times per week starting approximately on day 1 for three weeks and then once weekly for at least 6 doses
After completion of study therapy patients are followed periodically for up to 2 years after PBSC
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 |
|---|---|---|---|
| RWMC-0634246 | OTHER | MI172 | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-2007-033 | OTHER | None | None |