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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Thalidomide

Cisplatinum

Adriamycin

Cyclophosphamide

Etoposide

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, DTPACE, Dexamethasone, Thalidomide, Cisplatin, Cytoxan, Doxorubicin, Etoposide, Dendritic Cell Vaccination, Leukapheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Arkansas for Medical Sciences/MIRT

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00083538

First Posted

May 25, 2004

Last Updated

July 6, 2010

Sponsor

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT00083538

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Arkansas

4. Oversight

Data Monitoring Committee

No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, DTPACE, Dexamethasone, Thalidomide, Cisplatin, Cytoxan, Doxorubicin, Etoposide, Dendritic Cell Vaccination, Leukapheresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Intervention Type

Drug

Intervention Name(s)

Cisplatinum

Intervention Type

Drug

Intervention Name(s)

Adriamycin

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

Etoposide

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Van Rhee Frits, M.D.

Organizational Affiliation

UAMS

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arkansas for Medical Sciences/MIRT

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

12. IPD Sharing Statement

Links:

URL

http://myeloma.uams.edu

Description

Myeloma Institute for Research & Therapy website

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial