Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376805
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-09-13
Brief Title:
Allogeneic Natural Killer NK Cells in Patients With Advanced Metastatic Breast Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy before a donor natural killer NK cell infusion helps stop the growth of tumor cells It also helps stop the patients immune system from rejecting the donors cells Giving NK cells from a related donor may kill the tumor cells
PURPOSE This study furthers the research of previous studies MT2003-01 and MT2004-25 which were to determine a specific preparatory regimen cyclophosphamide and fludarabine could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML This study will test the previous regimen in patients with breast cancer
PURPOSE This study furthers the research of previous studies MT2003-01 and MT2004-25 which were to determine a specific preparatory regimen cyclophosphamide and fludarabine could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML This study will test the previous regimen in patients with breast cancer
Detailed Description:
We believe that administration of related allogeneic donor natural killer cells along with IL-2 rather than autologous natural killer cells will provide the most effective anticancer therapy in this setting and wish to test this approach To do this we will select a related donor who is partially HLA-matched with the study subject to increase the likelihood that donor natural killer cells will kill the subjects cancer cells We will also give chemotherapy drugs to increase the subjects tolerance for the donor natural killer cells We will test the use of donor natural killer NK cell infusions The immune system has a special way that it sees and identifies cancer cells or foreign agents like viruses The subjects own NK cells may not attack their cancer because NK cells see the tumor cells as self a coating on the cell surface identifies a cell as self or non-self We have reason to believe that NK cells may not kill cancer cells because NK cells have special receptors that turn them off when they encounter cancer cells by seeing them as self We may be able to get around this problem by using donor NK cells Finally subjects will receive a dose of subcutaneous IL-2 3 times a week for 2 weeks which has been proven safe in our previous studies to stimulate the natural killer cells
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 |
|---|---|---|---|
| UMN-0505M70037 | OTHER | None | None |
| UMN-MT2005-08 | OTHER | Blood and Bone Marrow Transplantation Program | None |