Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083538
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2004-05-25
Brief Title:
Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 2000-46 A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2010-07
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:
None
Brief Summary:
The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses
Detailed Description:
This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes In this protocol treatment will be given according to the risk group If there are certain abnormalities in the chromosomes the disease is considered to be high risk High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE after which the white blood cells will be collected Leukapheresis is a procedure in which blood is removed white blood cells are saved and the remaining blood is given back to you These dendritic cells will then be mixed with your individual myeloma protein andor cells and keyhole limpet hemocyanin KLH that is necessary for the enhancement of immune response against myeloma antigens It is hoped that this will cause these cells to interact with and activate T cells which will then destroy myeloma cells in your body Half of these white cells will be injected into your lymph nodes intranodally and half will be given subcutaneously High risk patients will receive a chemotherapy regimen called DT PACE
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