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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083538 |
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 | Intervention | Phase |
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Multiple Myeloma |
Drug: Dexamethasone Drug: Thalidomide Drug: Cisplatinum Drug: Adriamycin Drug: Cyclophosphamide Drug: Etoposide |
Phase II |
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 |
Enrollment: | 40 |
Study Start Date: | February 2001 |
Study Completion Date: | April 2005 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences/MIRT | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Van Rhee Frits, M.D. | UAMS |
Responsible Party: | UAMS ( Bart Barlogie, MD, PhD ) |
Study ID Numbers: | UARK 2000-46 |
Study First Received: | May 25, 2004 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00083538 History of Changes |
Health Authority: | United States: Institutional Review Board |
Multiple Myeloma DTPACE Dexamethasone Thalidomide Cisplatin |
Cytoxan Doxorubicin Etoposide Dendritic Cell Vaccination Leukapheresis |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Etoposide phosphate Anti-Bacterial Agents |
Hemorrhagic Disorders Cisplatin Etoposide Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Doxorubicin Multiple Myeloma |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Etoposide Immunoproliferative Disorders Immune System Diseases |
Antineoplastic Agents, Hormonal Hematologic Diseases Glucocorticoids Doxorubicin Multiple Myeloma Neoplasms Antineoplastic Agents, Phytogenic Leprostatic Agents Thalidomide Immunologic Factors Antineoplastic Agents Blood Protein Disorders Paraproteinemias Cyclophosphamide Hemostatic Disorders |