Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
N/A
N/A
Both
Lymphoproliferative Disorder
Trial Information
Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Efficacy of vaccine
Outcome Time Frame:
15 years
Safety Issue:
No
Principal Investigator
Richard F. Ambinder, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000445433 J0216
NCT ID:
NCT00278200
Start Date:
September 2002
Completion Date:
Related Keywords:
- Lymphoproliferative Disorder
- post-transplant lymphoproliferative disorder
- Lymphoproliferative Disorders
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
