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

Phase 1TerminatedNCT00278200

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoproliferative Disorder

Interventions

Inactivated EBV-infected vaccineBIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Efficacy of Vaccine as Assessed by T-cell Responses

Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.

Time frame: Up to 67 days

Secondary Outcomes

Adverse Events Associated With the Vaccine

Number of participants who received at least one vaccination and experienced at least one grade 3-4 adverse event by CTCAE 2.0 that was attributed to protocol therapy.

Time frame: Up to 5 years

Prevention of Primary Epstein-Barr Virus (EBV) Infection

Number of participants who were EBV-seronegative at baseline, received at least one vaccination, subsequently received a solid organ transplant (not part of this protocol), and did not develop a primary EBV infection.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.