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Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
This study is currently recruiting patients.
Sponsored by: | University of Arkansas
Celgene Corporation
Immunex Corporation
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Information provided by: | University of Arkansas |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Dexamethasone Drug: Thalidomide Drug: Cisplatinum Drug: Adriamycin Drug: Cyclophosphamide Drug: Etoposide |
Phase II |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 40
Study start: February 2001
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 and/or 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
Myeloma Institute for Research & Therapy website
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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