Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01232062
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2010-10-29
Brief Title:
Study of High-dose Chemotherapy HDC Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-07
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:
DC-CIK
Brief Summary:
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
Detailed Description:
1 Metastatic breast cancer patients should be definitively diagnosis based on histopathology with ER-negative and PR-negative FISH testing for her-2-negative
2 All the patients enrolled will be given standard HDC and cellular therapyHDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK DC-CIK infusions were given to each patient followed by two cycles HDC plus low-dose Oral Cyclophosphamide
3 PET-CT scans were done on each patients at baseline and after chemotherapy The response is assessed using Response Evaluation Criteria in Solid Tumor Group RECIST guidelines
4 Estimate time to progression survival rates and clinical benefit response on patients
5 Find biomarkers associated with drug response
2 All the patients enrolled will be given standard HDC and cellular therapyHDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK DC-CIK infusions were given to each patient followed by two cycles HDC plus low-dose Oral Cyclophosphamide
3 PET-CT scans were done on each patients at baseline and after chemotherapy The response is assessed using Response Evaluation Criteria in Solid Tumor Group RECIST guidelines
4 Estimate time to progression survival rates and clinical benefit response on patients
5 Find biomarkers associated with drug response
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