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

NCT ID: NCT00937183

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2017-12-31

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.

Conditions

Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine

Intervention Type: BIOLOGICAL

autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine

Intervention Type: BIOLOGICAL

autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jan Walewski

OTHER

Sponsor Role: lead

Responsible Party

Jan Walewski

Head, Dept. of Lymphoid Malignancies

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jan Walewski, MD

Role: STUDY_CHAIR

Maria Sklodowska-Curie National Research Institute of Oncology

Locations

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

CDR0000636859

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20913

Identifier Type: -

Identifier Source: secondary_id

MSCMI-40-2003

Identifier Type: -

Identifier Source: org_study_id