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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00278200
• Other study ID #: J0216
• Secondary ID: P30CA006973NA_00
• Status: Terminated
• Phase: Phase 1
• Start date: January 2003
• Est. completion date: August 2012

Study information

• Verified date: February 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoproliferative Disorder
• Lymphoproliferative Disorders

Intervention

Biological:
• Inactivated EBV-infected vaccine

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 67 days
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years