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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278200 |
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 |
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Lymphoproliferative Disorder |
Drug: autologous Epstein-Barr virus-transformed B-lymphoblastoid cell vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
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
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No history of autoimmune disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:
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 |
Study ID Numbers: | CDR0000445433, JHOC-J0216, JHOC-02060403 |
Study First Received: | January 16, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00278200 |
Health Authority: | United States: Food and Drug Administration |
post-transplant lymphoproliferative disorder |
Lymphatic Diseases Immunoproliferative Disorders Lymphoproliferative Disorders |
Pathologic Processes Disease Immune System Diseases |