Back to resultsDendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
Primary Purpose
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine
autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine
autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring dendritic cell vaccine, tumor cell lysate, lymphoma
Eligibility 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
Sites / Locations
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Outcomes
Primary Outcome Measures
Immune response
Progression-free survival
Adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937183
Brief Title
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
Official Title
Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jan Walewski
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
Keywords
dendritic cell vaccine, tumor cell lysate, lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine
Intervention Type
Biological
Intervention Name(s)
autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
Primary Outcome Measure Information:
Title
Immune response
Title
Progression-free survival
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Walewski, MD
Organizational Affiliation
Maria Sklodowska-Curie National Research Institute of Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
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