Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937183
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Walewski, Maria Sklodowska-Curie National Research Institute of Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.


Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Biological: autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine Biological: autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine Biological: autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine Not Applicable

Detailed Description:

OBJECTIVES:

  • Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
  • Evaluation of the immune response of patients treated with this regimen.
  • Evaluation the progression-free survival of patients treated this regimen.
  • Evaluate the adverse events of this regimen in these patients.

OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
Study Start Date : September 2003
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune response
  2. Progression-free survival
  3. Adverse events

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Mantle cell lymphoma
    • Marginal zone lymphoma
    • Follicular lymphoma
    • Small lymphocytic lymphoma/chronic lymphocytic leukemia
    • Multiple myeloma
    • Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
    • Diffuse large B-cell lymphoma
  • Adequate sample size and lymphoma cell content in the fresh tissue collected
  • No bulky or progressive disease

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
  • No autoimmune disease or atopic allergy
  • No HIV positivity
  • No other malignancy

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937183


Locations
Layout table for location information
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Sponsors and Collaborators
Jan Walewski
Investigators
Layout table for investigator information
Study Chair: Jan Walewski, MD Maria Sklodowska-Curie National Research Institute of Oncology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jan Walewski, Head, Dept. of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT00937183    
Other Study ID Numbers: MSCMI-40-2003
CDR0000636859 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20913
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by Jan Walewski, Maria Sklodowska-Curie National Research Institute of Oncology:
dendritic cell vaccine
tumor cell lysate
lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs