Trial Information
Vaccination of Lymphoma Patients With Dendritic Cell-Lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immune response
Safety Issue:
No
Principal Investigator
Jan Walewski, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Authority:
Unspecified
Study ID:
CDR0000636859
NCT ID:
NCT00937183
Start Date:
September 2003
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- 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
- stage III chronic lymphocytic leukemia
- Neoplasms
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Lymphoma, B-Cell