Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00937183|
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : August 19, 2019
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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|
- 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)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
- Immune response
- Progression-free survival
- Adverse events
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|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
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|
|Warsaw, Poland, 02-781|
|Study Chair:||Jan Walewski, MD||Maria Sklodowska-Curie National Research Institute of Oncology|
|Responsible Party:||Jan Walewski, Head, Dept. of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology|
|Other Study ID Numbers:||
CDR0000636859 ( Registry Identifier: PDQ (Physician Data Query) )
|First Posted:||July 10, 2009 Key Record Dates|
|Last Update Posted:||August 19, 2019|
|Last Verified:||August 2019|
dendritic cell vaccine
tumor cell lysate
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders
Physiological Effects of Drugs