Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
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ClinicalTrials.gov Identifier: NCT00509691 |
Recruitment Status
:
Completed
First Posted
: July 31, 2007
Last Update Posted
: May 9, 2017
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: flow cytometry Other: immunologic technique | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | 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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Single arm study | Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: flow cytometry Other: immunologic technique |
- Toxicity [ Time Frame: 1 year ]
- Treatment failure [ Time Frame: 1 year ]
- Safety [ Time Frame: 1 year ]
- Time to development of cytomegalovirus (CMV) specific immune reconstitution [ Time Frame: 1 year ]
- CMV DNA levels [ Time Frame: 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 [ Time Frame: 1 year ]

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Ages Eligible for Study: | 2 Years to 120 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509691
United States, Pennsylvania | |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 |
Principal Investigator: | Kenneth G. Lucas, MD | Milton S. Hershey Medical Center |
Responsible Party: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00509691 History of Changes |
Other Study ID Numbers: |
CDR0000557037 PSCI-25114 |
First Posted: | July 31, 2007 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
Keywords provided by University of Louisville:
infection adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic eosinophilic leukemia |
primary myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma |
Additional relevant MeSH terms:
Infection Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |