Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jan Walewski
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free survival
Adverse events
Immune response
Secondary Outcomes
No secondary outcomes reported
Investigators
Jan Walewski
Head, Dept. of Lymphoid Malignancies
Maria Sklodowska-Curie National Research Institute of Oncology