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Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00006434   Information provided by National Center for Research Resources (NCRR)
First Received: November 3, 2000   Last Updated: June 23, 2005   History of Changes

November 3, 2000
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00006434 on ClinicalTrials.gov Archive Site
 
 
 
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.

 
Phase III
Interventional
Treatment, Open Label
Lymphoma, Non-Hodgkin
Biological: tumor-pulsed dendritic cells
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
10 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006434
 
NCRR-M01RR00042-1694, M01RR00042
National Center for Research Resources (NCRR)
 
 
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP