Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00937183|
Recruitment Status : Unknown
Verified June 2011 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was: Recruiting
First Posted : July 10, 2009
Last Update Posted : December 7, 2016
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|
|Leukemia 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||Phase 1 Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|Official Title:||Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates|
|Study Start Date :||September 2003|
|Estimated Primary Completion Date :||June 2010|
- Immune response
- Progression-free survival
- Adverse events
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
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw||Recruiting|
|Warsaw, Poland, 02-781|
|Contact: Jan Walewski, MD 48-22-546-2223 email@example.com|
|Study Chair:||Jan Walewski, MD||Maria Sklodowska-Curie Institute - Oncology Center|