Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00937183
First received: July 8, 2009
Last updated: July 3, 2010
Last verified: July 2009
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Immune response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937183
Locations
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw | Recruiting |
| Warsaw, Poland, 02-781 | |
| Contact: Jan Walewski, MD 48-22-546-2223 walewski@coi.waw.pl | |
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
| Study Chair: | Jan Walewski, MD | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00937183 History of Changes |
| Other Study ID Numbers: | CDR0000636859, MSCMI-40/2003, EU-20913 |
| Study First Received: | July 8, 2009 |
| Last Updated: | July 3, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage II grade 1 follicular lymphoma stage II grade 2 follicular lymphoma stage II grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage I small lymphocytic lymphoma stage II small lymphocytic lymphoma stage III small lymphocytic lymphoma stage I marginal zone lymphoma |
stage II marginal zone lymphoma stage III marginal zone lymphoma stage I adult diffuse large cell lymphoma stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma recurrent mantle cell lymphoma stage I mantle cell lymphoma stage II mantle cell lymphoma stage III mantle cell lymphoma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Lymphoma, B-Cell Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on June 18, 2013