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Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
This study has been completed.
First Received: May 25, 2004   Last Updated: December 19, 2007   History of Changes
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083538
  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 Intervention Phase
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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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)
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 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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities
  • Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
  • Karnofsky performance score greater than or equal to 60
  • ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
  • Expected survival of 3 months or more
  • 18 years of age and older
  • Have given a written consent and been informed about the investigational nature of the study.
  • Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen

Exclusion Criteria:

  • Patients with CD4 count < 400/microliters, and/or with severely damaged immune functions
  • Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
  • Fever or active infection
  • Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN
  • Renal function: Patients on dialysis
  • Simultaneous treatment with a second investigational drug or biologic agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083538

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Van Rhee Frits, M.D. UAMS
  More Information

Additional Information:
No publications provided

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

Keywords provided by University of Arkansas:
Multiple Myeloma
DTPACE
Dexamethasone
Thalidomide
Cisplatin
Cytoxan
Doxorubicin
Etoposide
Dendritic Cell Vaccination
Leukapheresis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009