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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

This study has been completed.
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Kenneth Lucas, University of Louisville
ClinicalTrials.gov Identifier:
NCT00509691
First received: July 30, 2007
Last updated: June 10, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Treatment failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to development of cytomegalovirus (CMV) specific immune reconstitution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • CMV DNA levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 20
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Kenneth Lucas, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT00509691     History of Changes
Other Study ID Numbers: CDR0000557037  PSCI-25114 
Study First Received: July 30, 2007
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2016