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
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00509691 |
| Primary Contact: |
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Principal Investigator
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Clinical Trials Office - Penn State Hershey Cancer Institute a
Phone: 717-531-3779
Email: CTO@hmc.psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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