This trial is active, not recruiting.

Condition cancer
Treatments cytomegalovirus ie-1-specific cytotoxic t lymphocytes, cytomegalovirus pp65-specific cytotoxic t lymphocytes, therapeutic allogeneic lymphocytes, polymerase chain reaction, flow cytometry, immunological diagnostic method, laboratory biomarker analysis
Phase phase 1
Sponsor Milton S. Hershey Medical Center
Collaborator National Cancer Institute (NCI)
Start date August 2008
End date August 2014
Trial size 20 participants
Trial identifier NCT00769613, CDR0000615167, PSCI-PSHCI-08-051


RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.

PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose supportive care

Primary Outcomes

time frame:
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Secondary Outcomes

Time to development of cytomegalovirus (CMV)-specific immune reconstitution
time frame:
CMV DNA levels
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Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
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Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
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Eligibility Criteria

Male or female participants at least 2 years old.

DISEASE CHARACTERISTICS: - Recipient of an allogeneic stem cell transplantation - Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria: - Patient has a history of CMV antigenemia for ≥ 2 weeks - CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet) - No ongoing graft-vs-host disease - Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria: - CMV-seropositive donor (≥ 2 years of age) - CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients < 16 years of age) - Bilirubin < 2.0 mg/dL - AST and ALT < 2.5 times normal - Creatinine clearance ≥ 30 mL/min - Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask - Not moribund - No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion

Additional Information

Official title Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
Principal investigator Kenneth G. Lucas, MD
Description OBJECTIVES: Primary - To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation. Secondary - To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter. - To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus. - To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine. OUTLINE: This is a multicenter study. Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes 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- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. 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 therapy, patients are followed periodically for up to 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).