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

NCT ID: NCT00509691

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single arm study

Group Type: EXPERIMENTAL

cytomegalovirus pp65-specific cytotoxic T lymphocytes

Intervention Type: BIOLOGICAL

polymerase chain reaction

Intervention Type: GENETIC

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

flow cytometry

Intervention Type: OTHER

immunologic technique

Intervention Type: OTHER

Interventions

cytomegalovirus pp65-specific cytotoxic T lymphocytes

Intervention Type: BIOLOGICAL

polymerase chain reaction

Intervention Type: GENETIC

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

flow cytometry

Intervention Type: OTHER

immunologic technique

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Cytomegalovirus (CMV) seropositive

• Patient has had CMV antigenemia for ≥ 2 weeks OR CMV DNA levels ≥ 600 copies/μg of DNA despite antiviral therapy targeting CMV (ganciclovir or foscarnet)
• No prior allogeneic stem cell transplantation before the most recent transplantation
• CMV seropositive donor negative for HIV-1, HIV-2, HTLV-1/2 available

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2 (for patients ≤ 16 years of age) OR Lansky performance status 70-100%
• Bilirubin < 2.0 mg/dL
• AST and ALT < 2.5 times upper limit of normal
• Creatinine clearance > 50 mL/min
• Pulse oximetry > 95% without supplemental oxygen
• No history of graft-vs-host disease (GVHD) ≥ grade 2
• Not moribund
• No patients not expected to survive 1 month after T cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction

PRIOR CONCURRENT THERAPY:

• No concurrent systemic immunosuppressive agents for the treatment of GVHD

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth G. Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

PSCI-25114

Identifier Type: -

Identifier Source: secondary_id

CDR0000557037

Identifier Type: -

Identifier Source: org_study_id