Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00509691|
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : May 9, 2017
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|
- 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.
- 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|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
|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 ]
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|