Clinical trial NCT00937183: Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
Official title: Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Keywords: dendritic cell vaccine
tumor cell lysate
lymphoma
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Immune response
measure: Progression-free survival
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Jan Walewski, MD
role: STUDY_CHAIR
References: