Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma

Jan Walewski

Status: Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Lymphoma

Treatments: Biological: autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine; Biological: autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine; Biological: autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00937183

MSCMI-40-2003

EU-20913

CDR0000636859 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)