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OpenTrials
Completed

NCT Number: NCT00937183

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Immune response

  2. Progression-free survival

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Jan Walewski

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2009
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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