Status:
TERMINATED
Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoproliferative Disorder
Eligibility:
All Genders
Phase:
PHASE1
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 treatin...
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 antibod...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00278200
Start Date
January 1 2003
End Date
August 1 2012
Last Update
April 25 2023
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410