Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder
This trial is active, not recruiting.
|Treatment||autologous epstein-barr virus-transformed b-lymphoblastoid cell vaccine|
|Sponsor||Sidney Kimmel Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||September 2002|
|End date||December 2021|
|Trial size||40 participants|
|Trial identifier||NCT00278200, CDR0000445433 J0216, JHOC-02060403, JHOC-J0216, P30CA006973|
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.
Efficacy of vaccine
time frame: 15 years
Adverse events associated with the vaccine
time frame: 15 years
Male or female participants up to 120 years old.
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
|Official title||Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine|
|Principal investigator||Richard F. Ambinder, MD, PhD|
|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.|
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