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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:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00278200
First received: January 16, 2006
Last updated: June 16, 2014
Last verified: June 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
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: June 16, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014