NCT00769613

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

December 18, 2013

Status Verified

August 1, 2010

Enrollment Period

6 years

First QC Date

October 8, 2008

Last Update Submit

December 17, 2013

Conditions

Cancer

Keywords

stage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromeextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomaaccelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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)atypical chronic myeloid leukemia, BCR-ABL1 negativeblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiajuvenile myelomonocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiachildhood myelodysplastic syndromeschronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiade novo myelodysplastic syndromesdisseminated neuroblastomamyelodysplastic/myeloproliferative neoplasm, unclassifiablehigh risk metastatic gestational trophoblastic tumorpreviously treated childhood rhabdomyosarcomapreviously treated myelodysplastic syndromesrecurrent Wilms tumor and other childhood kidney tumorsrecurrent childhood rhabdomyosarcomarecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent malignant testicular germ cell tumorsecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomastage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerstage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrefractory multiple myelomacytomegalovirus infection

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Toxicity

Secondary Outcomes (4)

  • Time to development of cytomegalovirus (CMV)-specific immune reconstitution

  • CMV DNA levels

  • 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)

  • Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors

Interventions

cytomegalovirus IE-1-specific cytotoxic T lymphocytesBIOLOGICAL
cytomegalovirus pp65-specific cytotoxic T lymphocytesBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
polymerase chain reactionGENETIC
flow cytometryOTHER
immunological diagnostic methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

NeoplasmsBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousRecurrenceMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, JuvenileLeukemia, Myeloid, AcuteLeukemia, Hairy CellPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicMyeloproliferative DisordersWilms TumorNeuroblastomaCarcinoma, Ovarian EpithelialTesticular NeoplasmsMultiple MyelomaBreast NeoplasmsCytomegalovirus Infections

Interventions

Polymerase Chain ReactionFlow Cytometry

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Kenneth G. Lucas, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2014

Last Updated

December 18, 2013

Record last verified: 2010-08

Locations

US(1)