Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
Recruitment status was: Recruiting
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.
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
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates|
- Immune response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||September 2003|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937183
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw|
|Warsaw, Poland, 02-781|
|Study Chair:||Jan Walewski, MD||Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology|