Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03209869
Status:
WITHDRAWN
Last Update Posted:
2022-09-13
First Post:
2017-06-13
Brief Title:
Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu1418-IL2
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Ex-Vivo Expanded and Activated Haploidentical NK Cells and Hu1418-IL2
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
resources limited due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects with relapsed or refractory neuroblastoma and osteosarcoma will receive ex-vivo expanded and activated natural killer NK cells from a haploidentical donor in conjunction with the immunocytokine hu1418-IL2
Detailed Description:
Natural Killer cells a type of white blood cell circulate around the body and kill abnormal cells cells that are malignant damaged or infected with virus Sometimes cancer cells adapt to the bodys own NK cells and are able to avoid being killed by them This clinical trial uses two strategies to overcome the cancer cells ability to avoid NK cell-mediated death
The first strategy involves giving NK cells from another individual to the patient in other words donor- or haploidentical-NK cells This is done because NK cells from an individual who is haploidentical half-matched genetic make-up are still able to effectively kill the cancer cells Unfortunately only a limited number of NK cells can be obtained from a donor So to increase the number of cancer-killing NK cells that will be given to the patient the donor NK cells will first be grown in a sterile laboratory environment and allowed to multiply many-fold before they are infused into the patient This growing process also activates the donor NK cells which increases their ability to kill cancer cells
The second strategy to overcome the cancer cells ability to avoid NK cell-mediated death is to administer the immunocytokine hu1418-IL2 every day for seven days after infusion of the donor NK cells The antibody portion hu1418 of the immunocytokine molecule flags the neuroblastoma cells for destruction by NK cells and the cytokine portion IL2 further activates the NK cells as well as other anti-tumor immune effector cells
Since the donor NK cells are from a haploidentical individual they are different enough to be recognized as foreign cells and will be killed immediately rejected by the patients own immune system unless the immune system is restrained So to allow the donor NK cells time to kill neuroblastoma cells before they are rejected a chemotherapy regimen is first given to the patient to temporarily restrain the patients own immune system This also allows room for the donor NK cells to live multiply and function
Four courses of treatment are planned for each subject Each course of treatment will be approximately one month long and involves a week of chemotherapy followed by infusion of donor NK cells Beginning the day after the donor NK cell infusion hu1418-IL2 is infused over four hours for seven consecutive days
The first strategy involves giving NK cells from another individual to the patient in other words donor- or haploidentical-NK cells This is done because NK cells from an individual who is haploidentical half-matched genetic make-up are still able to effectively kill the cancer cells Unfortunately only a limited number of NK cells can be obtained from a donor So to increase the number of cancer-killing NK cells that will be given to the patient the donor NK cells will first be grown in a sterile laboratory environment and allowed to multiply many-fold before they are infused into the patient This growing process also activates the donor NK cells which increases their ability to kill cancer cells
The second strategy to overcome the cancer cells ability to avoid NK cell-mediated death is to administer the immunocytokine hu1418-IL2 every day for seven days after infusion of the donor NK cells The antibody portion hu1418 of the immunocytokine molecule flags the neuroblastoma cells for destruction by NK cells and the cytokine portion IL2 further activates the NK cells as well as other anti-tumor immune effector cells
Since the donor NK cells are from a haploidentical individual they are different enough to be recognized as foreign cells and will be killed immediately rejected by the patients own immune system unless the immune system is restrained So to allow the donor NK cells time to kill neuroblastoma cells before they are rejected a chemotherapy regimen is first given to the patient to temporarily restrain the patients own immune system This also allows room for the donor NK cells to live multiply and function
Four courses of treatment are planned for each subject Each course of treatment will be approximately one month long and involves a week of chemotherapy followed by infusion of donor NK cells Beginning the day after the donor NK cell infusion hu1418-IL2 is infused over four hours for seven consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P30CA014520 | NIH | None | None |
| 2016-1195 | OTHER | None | None |
| A536755 | OTHER | None | None |
| SMPHPEDIATRICSPEDIATRICS | OTHER | None | None |
| NCI-2017-01267 | REGISTRY | None | None |
| Protocol V12 01302021 | OTHER | UW Madison | httpsreporternihgovquickSearchP30CA014520 |