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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.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00278200
First received: January 16, 2006
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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
 Biological: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Efficacy of vaccine [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events associated with the vaccine [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]

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

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00278200     History of Changes
Other Study ID Numbers: CDR0000445433 J0216, P30CA006973, JHOC-J0216, JHOC-02060403
Study First Received: January 16, 2006
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
post-transplant lymphoproliferative disorder

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013