Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD

Lymphoproliferative Disorder Clinical Trial

Official title: Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lymphoproliferative Disorder
• Lymphoproliferative Disorders

• NCT number: NCT00278200
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Status: Terminated
• Phase: Phase 1
• Start date: January 2003
• Completion date: August 2012