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

Lymphoma Clinical Trial

Official title:

Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937183
• Other study ID #: MSCMI-40-2003
• Secondary ID: CDR0000636859EU-
• Status: Completed
• Phase: N/A
• Start date: September 2003
• Est. completion date: December 2017

Study information

• Verified date: August 2019
• Source: Maria Sklodowska-Curie Institute - Oncology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine

• autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine

• autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Jan Walewski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response
Primary	Progression-free survival
Primary	Adverse events