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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

July 30, 2007
June 10, 2013
June 2007
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Toxicity
  • Treatment failure
  • Safety
Complete list of historical versions of study NCT00509691 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to development of cytomegalovirus (CMV) specific immune reconstitution
  • CMV DNA levels
  • 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
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
  • Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes
  • Genetic: polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
  • Other: flow cytometry
  • Other: immunologic technique
Experimental: Single arm study
Interventions:
  • Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes
  • Genetic: polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
  • Other: flow cytometry
  • Other: immunologic technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00509691
CDR0000557037, PSCI-25114
Yes
Kenneth Lucas, University of Louisville
University of Louisville
Penn State University
Principal Investigator: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
University of Louisville
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP