Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD
| Status: | Terminated |
|---|---|
| Conditions: | Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/28/2019 |
| Start Date: | January 2003 |
| End Date: | August 2012 |
Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
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.
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.
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.
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.
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
We found this trial at
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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