Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099593
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2004-12-17
Brief Title:
Immunization Against Tumor Cells in Sezary Syndrome
Sponsor:
University of Pittsburgh
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells
Status:
COMPLETED
Status Verified Date:
2006-12
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:
None
Brief Summary:
This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma CTCL and Sezary Syndrome
In the laboratory researches found that special white blood cells called dendritic cells DCs are able to stimulate the immune system groups of cells that protect the body from germs and diseases in a way that helps your body fight cancer Autologous from your own body DCs will be prepared mixed together in the laboratory with your cancer cell Sezary cells to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you
In the laboratory researches found that special white blood cells called dendritic cells DCs are able to stimulate the immune system groups of cells that protect the body from germs and diseases in a way that helps your body fight cancer Autologous from your own body DCs will be prepared mixed together in the laboratory with your cancer cell Sezary cells to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you
Detailed Description:
Although the etiology of CTCL is not completely understood immunologic factors appear to play an important role
Dendritic Cell DC-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors Importantly DC-tumor cell immunization has the potential to simultaneously stimulate CD4 and CD8 T cell-mediated immunity against multiple tumor antigens
The vaccine will be prepared from the subjects own blood obtained during leukapheresis From leukapheresed blood monocyte-derived DCs and malignant lymphocytes will be isolated The DCs will then be loaded with lymphocyte-derived tumor antigens Formulations and release criteria must be met before vaccine can be administered
Completion date provided represents the completion date of the grant per OOPD records
Dendritic Cell DC-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors Importantly DC-tumor cell immunization has the potential to simultaneously stimulate CD4 and CD8 T cell-mediated immunity against multiple tumor antigens
The vaccine will be prepared from the subjects own blood obtained during leukapheresis From leukapheresed blood monocyte-derived DCs and malignant lymphocytes will be isolated The DCs will then be loaded with lymphocyte-derived tumor antigens Formulations and release criteria must be met before vaccine can be administered
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| FD-R-002545-01 | None | None | None |