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

NCT00937183 | Completed

• 3 other identifiers: MSCMI-40-2003CDR0000636859EU-20913
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Keywords

dendritic cell vaccine; tumor cell lysate; lymphoma

Outcome Measures

Primary Outcomes (3)

• Immune response

• Progression-free survival

• Adverse events

Interventions

autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine BIOLOGICAL

autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine BIOLOGICAL

autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jan Walewski: lead

Study Sites (1)

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

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Jan Walewski, MD

  Maria Sklodowska-Curie National Research Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Dept. of Lymphoid Malignancies

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: September 1, 2003
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

PL (1)