Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally

University of Arkansas

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Dexamethasone

Drug: Adriamycin

Drug: Etoposide

Drug: Thalidomide

Drug: Cyclophosphamide

Drug: Cisplatinum

Study type

Interventional

Funder types

Other

Identifiers

NCT00083538

UARK 2000-46

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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