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Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278200
  Purpose

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.


Condition Intervention Phase
Lymphoproliferative Disorder
Drug: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine
Phase I

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized
Official Title:   Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   40
Study Start Date:   September 2002
Estimated Primary Completion Date:   December 2021 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of photochemically-treated autologous Epstein-Barr virus (EBV)-transformed B-lymphoblastoid cell vaccine in generating an EBV-specific T-cell and antibody response in EBV-negative patients or in boosting the response in EBV-positive patients who are being considered for a solid organ transplant and are at high risk for post-transplant lymphoproliferative disorder.
  • Determine adverse events associated with this vaccine in these patients.
  • Determine the ability of the vaccine to protect from EBV primary infection in EBV-seronegative patients during the time course of the study.

OUTLINE: This is a nonrandomized, pilot study. Patients are stratified according to Epstein-Barr virus (EBV) status (seropositive vs seronegative).

Patients receive photochemically-treated autologous EBV-transformed B-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Being considered for a solid organ transplant
  • At high risk for post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

  • Body weight ≥ 25 kg
  • Karnofsky performance status 50-100% OR
  • Lansky performance status 50-100%
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use contraception during and for 2 months after completion of study treatment
  • Hemoglobin ≥ 8 g/dL (erythropoietin allowed)
  • No history of autoimmune disease, including any of the following:

    • Systemic lupus erythematosus
    • Sarcoidosis
    • Rheumatoid arthritis
    • Glomerulonephritis
    • Vasculitis
  • No primary immunodeficiency
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:

    • Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency
    • Inhaled steroids
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278200

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins    
      Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Richard F. Ambinder, MD, PhD     Sidney Kimmel Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000445433, JHOC-J0216, JHOC-02060403
First Received:   January 16, 2006
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00278200
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
post-transplant lymphoproliferative disorder  

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Immune System Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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