Status:
COMPLETED
Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00083538
Start Date
February 1 2001
End Date
December 1 2007
Last Update
July 7 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205