Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Milton S. Hershey Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00509691
First received: July 30, 2007
Last updated: August 18, 2011
Last verified: October 2007
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
neuroblastoma
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Cytomegalovirus Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Toxicity
- Treatment failure
- Safety
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509691
Locations
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
| Principal Investigator: | Kenneth G. Lucas, MD | Milton S. Hershey Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00509691 History of Changes |
| Other Study ID Numbers: | CDR0000557037, PSCI-25114 |
| Study First Received: | July 30, 2007 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia 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 juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Herpesviridae Infections DNA Virus Infections Virus Diseases Lymphoma |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013