Vaccine Therapy in Treating Patients Who Have Undergone a... | NCT00509691 | Trialant
NCT00509691
Sponsor
University of Louisville
Status
Completed
Last Update Posted
May 9, 2017Actual
Enrollment
20Actual
Phase
Phase 1
Conditions
Cancer
Interventions
cytomegalovirus pp65-specific cytotoxic T lymphocytes
polymerase chain reaction
diagnostic laboratory biomarker analysis
flow cytometry
immunologic technique
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00509691
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000557037
Secondary IDs
ID
Type
Description
Link
PSCI-25114
Brief Title
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
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
Acronym
Not provided
Organization
University of LouisvilleOTHER
Status Module
Record Verification Date
May 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2007
Primary Completion Date
Dec 2011Actual
Completion Date
Dec 2011Actual
First Submitted Date
Jul 30, 2007
First Submission Date that Met QC Criteria
Jul 30, 2007
First Posted Date
Jul 31, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 8, 2017
Last Update Posted Date
May 9, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of LouisvilleOTHER
Collaborators
Name
Class
Penn State University
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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)
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
20Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Single arm study
Experimental
Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes
Genetic: polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: immunologic technique
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cytomegalovirus pp65-specific cytotoxic T lymphocytes
Biological
Single arm study
polymerase chain reaction
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Toxicity
1 year
Treatment failure
1 year
Safety
1 year
Secondary Outcomes
Measure
Description
Time Frame
Time to development of cytomegalovirus (CMV) specific immune reconstitution
1 year
CMV DNA levels
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
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
120 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey
Pennsylvania
17033-0850
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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