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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
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
University of Louisville

Study Description
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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.


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

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 Design
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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: B-cell Lymphoma Myelodysplastic Syndromes Lymphosarcoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Childhood Acute Lymphoblastic Leukemia Ovarian Epithelial Cancer Multiple Myeloma Neuroblastoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Hodgkin Lymphoma Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Burkitt Lymphoma Diffuse Large B-Cell Lymphoma Testicular Cancer Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Wilms' Tumor Cytomegalic Inclusion Disease Lymphoma, Large-cell Hairy Cell Leukemia Hodgkin Lymphoma, Childhood Gestational Trophoblastic Tumor Myelofibrosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Toxicity [ Time Frame: 1 year ]
  2. Treatment failure [ Time Frame: 1 year ]
  3. Safety [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to development of cytomegalovirus (CMV) specific immune reconstitution [ Time Frame: 1 year ]
  2. CMV DNA levels [ Time Frame: 1 year ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
University of Louisville
Penn State University
Investigators
Principal Investigator: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
More Information
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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