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


Phase 1
N/A
N/A
Open (Enrolling)
Both
Lymphoproliferative Disorder

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Efficacy of vaccine

Outcome Time Frame:

15 years

Safety Issue:

No

Principal Investigator

Richard F. Ambinder, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000445433 J0216

NCT ID:

NCT00278200

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Lymphoproliferative Disorder
  • post-transplant lymphoproliferative disorder
  • Lymphoproliferative Disorders

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410