Ignite Creation Date:
2024-05-05 @ 10:36 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01147016
Status:
TERMINATED
Last Update Posted:
2023-04-27
First Post:
2010-06-17
Brief Title:
Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase II Study of Anti-CD3 x Anti-HER2Neu Her2Bi Armed Activated T Cells ATC After Neoadjuvant Chemotherapy in Women With HER2Neu 0-2 Hormone Receptor HR Negative Stage II-III Breast Cancers
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary co-investigator leaving the institution funding transfer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells ATCs may significantly improve the pathologic complete response pCR rate at the time of surgery Arming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery
PURPOSE This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery
Detailed Description:
PRIMARY OBJECTIVES
I To estimate progression-free survival PFS in women with stage II-III triple-negative breast cancer without a complete pathologic response cPR who receive a regimen of neoadjuvant chemotherapy chemoT surgery andor irradiation followed by 8 infusions of 10-15 x 109 Her2Bi-armed activated T cells ATC aATC given twice per week for 4 weeks in combination with IL-2 aldesleukin 300000 IUm2day and GM-CSF sargramostim 250 μgm2twice per week beginning 3 days before the 1st infusion and ending 1 week after the last infusion defined as immunotherapy
II To estimate the change from baseline pre immunotherapy IT to post-IT in specific cytotoxicity and interferon gamma IFN-γ enzyme-linked immunosorbent spots Elispots of lymphocytes in the blood directed at breast cancer cells
III To investigate if pathologic response and the changes in numbers and proportion of infiltrating cells and cancer stem cells in the tumor at the time of surgery are associated with progressive disease
OUTLINE
NEOADJUVANT CHEMOTHERAPY Patients receive dose-dense AC-T regimen comprising doxorubicin hydrochloride intravenously IV and cyclophosphamide IV once every 2 weeks for 4 courses followed by paclitaxel IV once every 2 weeks for 4 courses or paclitaxel IV once weekly for 12 weeks Or patients receive TAC regimen comprising docetaxel IV doxorubicin hydrochloride IV and cyclophosphamide IV once every 3 weeks for 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity
IMMUNOTHERAPY Beginning 3 weeks after the last dose of chemotherapy patients receive Her2Bi-armed activated T cells IV over 5-30 minutes twice weekly for 4 weeks Patients also receive aldesleukin subcutaneously SC daily beginning 3 days before the first T cell infusion and ending 1 week after the last infusion
SURGERY Patients then undergo surgical resection of the breast 2 weeks later
After completion of study treatment patients may be followed up at 1 3 6 and 12 months
I To estimate progression-free survival PFS in women with stage II-III triple-negative breast cancer without a complete pathologic response cPR who receive a regimen of neoadjuvant chemotherapy chemoT surgery andor irradiation followed by 8 infusions of 10-15 x 109 Her2Bi-armed activated T cells ATC aATC given twice per week for 4 weeks in combination with IL-2 aldesleukin 300000 IUm2day and GM-CSF sargramostim 250 μgm2twice per week beginning 3 days before the 1st infusion and ending 1 week after the last infusion defined as immunotherapy
II To estimate the change from baseline pre immunotherapy IT to post-IT in specific cytotoxicity and interferon gamma IFN-γ enzyme-linked immunosorbent spots Elispots of lymphocytes in the blood directed at breast cancer cells
III To investigate if pathologic response and the changes in numbers and proportion of infiltrating cells and cancer stem cells in the tumor at the time of surgery are associated with progressive disease
OUTLINE
NEOADJUVANT CHEMOTHERAPY Patients receive dose-dense AC-T regimen comprising doxorubicin hydrochloride intravenously IV and cyclophosphamide IV once every 2 weeks for 4 courses followed by paclitaxel IV once every 2 weeks for 4 courses or paclitaxel IV once weekly for 12 weeks Or patients receive TAC regimen comprising docetaxel IV doxorubicin hydrochloride IV and cyclophosphamide IV once every 3 weeks for 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity
IMMUNOTHERAPY Beginning 3 weeks after the last dose of chemotherapy patients receive Her2Bi-armed activated T cells IV over 5-30 minutes twice weekly for 4 weeks Patients also receive aldesleukin subcutaneously SC daily beginning 3 days before the first T cell infusion and ending 1 week after the last infusion
SURGERY Patients then undergo surgical resection of the breast 2 weeks later
After completion of study treatment patients may be followed up at 1 3 6 and 12 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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-2010-056 | OTHER | Barbara Ann Karmanos Institute | httpsreporternihgovquickSearchP30CA022453 |