Clinical trial NCT00278200: Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD
Official title: Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoproliferative Disorder
Keywords: post-transplant lymphoproliferative disorder
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-18
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Vaccine as Assessed by T-cell Responses
timeFrame: Up to 67 days
Secondary outcomes:
measure: Adverse Events Associated With the Vaccine
timeFrame: Up to 5 years
measure: Prevention of Primary Epstein-Barr Virus (EBV) Infection
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Richard F Ambinder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: