Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder
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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.
Condition | Intervention | Phase |
---|---|---|
Lymphoproliferative Disorder |
Biological: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
Official Title: | Vaccination of Patients at High Risk for Post-Transplant Lymphoproliferative Disorder With a Photochemically Inactivated EBV-Infected B-Cell Vaccine |
Estimated Enrollment: | 40 |
Study Start Date: | September 2002 |
Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
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.
![](https://webarchive.library.unt.edu/web/20121017194231im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20121017194231im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Principal Investigator: | Richard F. Ambinder, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
![](https://webarchive.library.unt.edu/web/20121017194231im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00278200 History of Changes |
Other Study ID Numbers: | CDR0000445433 J0216, P30CA006973, JHOC-J0216, JHOC-02060403 |
Study First Received: | January 16, 2006 |
Last Updated: | January 25, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
post-transplant lymphoproliferative disorder |
Additional relevant MeSH terms:
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on October 16, 2012