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

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006434
First received: November 3, 2000
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
 Biological: tumor-pulsed dendritic cells
 Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006434

Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48104-0914
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006434     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1694, M01RR00042
Study First Received: November 3, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
Dendritic cells

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013