This trial is active, not recruiting.

Condition lymphoproliferative disorder
Treatment autologous epstein-barr virus-transformed b-lymphoblastoid cell vaccine
Phase phase 1
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Primary purpose treatment

Primary Outcomes

Efficacy of vaccine
time frame: 15 years

Secondary Outcomes

Adverse events associated with the vaccine
time frame: 15 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.