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

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00006434
Collaborator
(none)
1
Location

Study Details

Study Description

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
  • Biological: tumor-pulsed dendritic cells
 Phase 3

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Michigan Medical Center Ann Arbor Michigan United States 48104-0914

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006434
    Other Study ID Numbers:
    • NCRR-M01RR00042-1694
    • M01RR000042
    First Posted:
    Nov 6, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 2003
    Keywords provided by , ,
    Dendritic cells
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of Jun 24, 2005