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

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.

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