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Completed

NCT Number: NCT00006434

Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma

When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it. This study is being conducted to determine the safety, side effects, and the ability to respond to an investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from the blood, and are important in the body's immune response to foreign substances. This study will examine the response of the immune system after three vaccinations (composed of dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning three months after transplant. Vaccination may result in sensitizing the patient's dendritic cells to his lymphoma cells, potentially resulting in an immune response against the lymphoma. Twelve patients will be treated on study.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48104-0914, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically documented, aggressive and/or intermediate grade NHL, B-cell and T-cell.
  • In relapse after first-line conventional chemotherapy. Primary therapy should include a doxorubicin-based regimen.
  • Patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. Successful treatment of CNS or meningeal disease is allowed.
  • Patients must have accessible tumor for biopsy or excision.
  • Cumulative total doxorubicin: <500 mg/m2
  • Performance score 0-2
  • No prior pelvic RT
  • Patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease.
  • Patients may not be taking immunosuppressive agents.
  • Informed Consent; IRB approval

Treatment and study plan

tumor-pulsed dendritic cells

Biological

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Registry information

Important dates

First posted
Nov 6, 2000
Registry last updated
Jun 24, 2005

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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