NCT00509691

Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy

A Phase I Trial to Examine the Safety, Clinical, Immunologic and Virologic Effects of CMV pp65 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistent or Therapy Refractory Infections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 2 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy.

Detailed description

OBJECTIVES: Primary * To determine the safety of infusing cytomegalovirus (CMV) pp65-specific cytotoxic T-lymphocytes (CTL) generated using pp65 peptides in patients who have undergone allogeneic stem cell transplantation and have persistent CMV infections. Secondary * Characterize CMV pp65-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter. * Characterize the levels of CMV DNA in recipients of CMV pp65 CTL and observe whether the CTL infusion has any impact on the level of virus. OUTLINE: This is a multicenter study. Patients receive cytomegalovirus (CMV) pp65 cytotoxic T-cell infusion on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose. Blood samples are collected and analyzed by quantitative CMV PCR, chromium release assays for CMV pp65-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45 RA/RD. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells. After completion of study treatment, patients are followed periodically for up to 1 year.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cytomegalovirus pp65-specific cytotoxic T lymphocytes
GENETIC	polymerase chain reaction
OTHER	diagnostic laboratory biomarker analysis
OTHER	flow cytometry
OTHER	immunologic technique

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-07-31
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States