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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006434
Recruitment Status : Completed
First Posted : November 6, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Biological: tumor-pulsed dendritic cells Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Vaccines

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006434


Locations
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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
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ClinicalTrials.gov Identifier: NCT00006434    
Other Study ID Numbers: NCRR-M01RR00042-1694
M01RR000042 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003
Keywords provided by National Center for Research Resources (NCRR):
Dendritic cells
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases