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

Status: Terminated
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

∙ 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

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Time Frame
Start Date: 2003-01
Completion Date: 2012-08
Participants
Target number of participants: 23
Treatments
Experimental: EBV Seronegative
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
Experimental: EBV Seropositive
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov