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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
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

Further Study Details: 

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


Arkansas
      University of Arkansas for Medical Sciences/MIRT, Little Rock,  Arkansas,  72205,  United States; Recruiting
Mark A Mosby, BS, CCRP  501-296-1503  Ext. 1543    mosbymarka@uams.edu 
Cherie L Harless  501-296-1503  Ext. 1463    HarlessCherieL@uams.edu 
Athanasios Fassas, M.D.,  Sub-Investigator
Bart Barlogie, M.D., Ph.D.,  Sub-Investigator
Guido Tricot, M.D., Ph.D.,  Sub-Investigator
Elias Anaissie, M.D.,  Sub-Investigator
Frits Van Rhee, M.D., Ph.D.,  Principal Investigator
Maurizio Zangari, M.D.,  Sub-Investigator
Choon K Lee, M.D.,  Sub-Investigator
Raymond Thertulien, M.D., Ph.D.,  Sub-Investigator
Elias Kiwan, M.D.,  Sub-Investigator
Giampaolo Talamo, M.D.,  Sub-Investigator
Charles Wendling, M.D.,  Sub-Investigator
Klaus Hollmig, M.D.,  Sub-Investigator
John Shaughnessy, Ph.D.,  Sub-Investigator
Sanjaya Viswanitra, M.D.,  Sub-Investigator
Timothy McCowan, M.D.,  Sub-Investigator
Jean Matchett, M.D.,  Sub-Investigator
William Culp, M.D.,  Sub-Investigator
John Crowley, Ph.D.,  Sub-Investigator
Michelle Fox, M.D.,  Sub-Investigator
Somashekar Krishna, M.D.,  Sub-Investigator
Richard Reinholtz, M.D.,  Sub-Investigator
H.R. Shah, M.D.,  Sub-Investigator
H.J. Spencer, M.S.,  Sub-Investigator

Study chairs or principal investigators

Van Rhee Frits, M.D.,  Principal Investigator,  UAMS   

More Information

Myeloma Institute for Research & Therapy website

Study ID Numbers:  UARK 2000-46
Record last reviewed:  September 2004
Record first received:  May 25, 2004
ClinicalTrials.gov Identifier:  NCT00083538
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16
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