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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes; Genetic: polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Other: flow cytometry; Other: immunologic technique

• Registration Number: NCT00509691
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	polymerase chain reaction	-
Single arm study	cytomegalovirus pp65-specific cytotoxic T lymphocytes	-
Single arm study	immunologic technique	-
Single arm study	diagnostic laboratory biomarker analysis	-
Single arm study	flow cytometry	-

Primary Outcome Measures

Name	Time	Method
Toxicity	1 year
Safety	1 year
Treatment failure	1 year

Secondary Outcome Measures

Name	Time	Method
CMV DNA levels	1 year
Time during post-infusion follow up at which the dominant CMV pp65 epitope for the donor is recognized by the cytotoxic t-cell lymphocyte recipient	1 year
Time to development of cytomegalovirus (CMV) specific immune reconstitution	1 year

Trial Locations

Locations (1)

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States