2015
Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma
Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica 2015, 100: 794-800. PMID: 25795722, PMCID: PMC4450625, DOI: 10.3324/haematol.2015.123711.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaComplete remissionRecombinant immunotoxinCommon adverse eventsDose-escalation trialLow tumor burdenAssessment Tool scoreDurable remissionsEscalation trialPartial remissionAdverse eventsTumor burdenIntravenous infusionPatientsRemissionTool scoreResponse rateSingle-chain antibody fragmentChain antibody fragmentsLymphomaDiphtheria toxinFurther studiesImmunotoxinTrials
2013
A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study
Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leukemia & Lymphoma 2013, 54: 1373-1379. PMID: 23278639, DOI: 10.3109/10428194.2012.742521.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaDenileukin diftitoxT-cell lymphomaAdverse eventsOverall survivalFrequent treatment-related adverse eventsUntreated peripheral T-cell lymphomaMedian progression-free survivalMost frequent adverse eventsMulticenter phase II trialTreatment-related adverse eventsTreatment-related deathsFrequent adverse eventsMedian overall survivalPhase II studyPhase II trialProgression-free survivalOverall survival rateOverall response rateITT populationSafety populationII trialII studyMedian durationLarge trials
2011
Predictors of complete responses with denileukin diftitox in cutaneous T‐cell lymphoma
Foss F, Duvic M, Olsen EA. Predictors of complete responses with denileukin diftitox in cutaneous T‐cell lymphoma. American Journal Of Hematology 2011, 86: 627-630. PMID: 21674574, DOI: 10.1002/ajh.22039.Peer-Reviewed Original Research
2007
Cutaneous T-cell lymphoma: Biologic targets for therapy
Choi J, Foss F. Cutaneous T-cell lymphoma: Biologic targets for therapy. Current Hematologic Malignancy Reports 2007, 2: 272-277. PMID: 20425380, DOI: 10.1007/s11899-007-0037-8.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsApoptosisCD4 AntigensClinical Trials as TopicDiphtheria ToxinDrug Delivery SystemsDrug DesignEpigenesis, GeneticGene Expression Regulation, NeoplasticHumansImmunologic FactorsImmunotherapyInterferon-gammaInterleukin-2Lymphoma, T-Cell, CutaneousNeoplasm ProteinsPhotopheresisRecombinant Fusion ProteinsSkin NeoplasmsT-Lymphocyte SubsetsTumor EscapeConceptsCutaneous T-cell lymphomaReceptor-dependent signaling pathwaysEpigenetic changesSignaling pathwaysClonal populationsSkin-homing lymphocytesT-cell lymphomaT cell activationPersistence of tumorHost immune systemCTCL cellsCancer immunosurveillanceImmune cellsLangerhans cellsCytotoxic phenotypeDisease pathogenesisBiologic targetsImmune systemCellsTherapyDiseasePhenotypePathwayImmunosurveillanceActivationEfficacy of Denileukin Diftitox in Subcutaneous Panniculitis-Like T-Cell Lymphoma
Hathaway T, Subtil A, Kuo P, Foss F. Efficacy of Denileukin Diftitox in Subcutaneous Panniculitis-Like T-Cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2007, 7: 541-545. PMID: 18021473, DOI: 10.3816/clm.2007.n.040.Peer-Reviewed Original ResearchConceptsT-cell phenotypeDenileukin diftitoxSubcutaneous panniculitis-like T-cell lymphomaPanniculitis-like T-cell lymphomaSubcutaneous panniculitis-like lymphomaSystemic multi-agent chemotherapyAddition of bexaroteneMedian response durationMulti-agent chemotherapyComplete clinical regressionBone marrow transplantationT-cell lymphomaPleomorphic lymphocytesImmunosuppressive therapyRefractory patientsClinical regressionClinical responseMost patientsMarrow transplantationAggressive diseasePrognostic significanceDisease progressionRadiation therapyTraditional therapiesResponse duration
2006
Biologic Correlates of Response and Survival in Patients with Cutaneous T-Cell Lymphoma Treated with Denileukin Diftitox
Chin KM, Foss FM. Biologic Correlates of Response and Survival in Patients with Cutaneous T-Cell Lymphoma Treated with Denileukin Diftitox. Clinical Lymphoma Myeloma & Leukemia 2006, 7: 199-204. PMID: 17229335, DOI: 10.3816/clm.2006.n.059.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsCD4-Positive T-LymphocytesClinical Trials as TopicDiphtheria ToxinFemaleHumansInterleukin-2Interleukin-2 Receptor alpha SubunitLymphoma, T-Cell, CutaneousMaleMiddle AgedMycosis FungoidesReceptors, Interleukin-2Recombinant Fusion ProteinsSkin NeoplasmsTreatment OutcomeConceptsCutaneous T-cell lymphomaAdvanced stage diseaseT-cell lymphomaDenileukin diftitoxMedian survivalBiologic correlatesAdvanced-stage cutaneous T-cell lymphomaResponse ratePhase III registration trialNumber of CD4Single-center seriesAbsolute lymphocyte countOverall response rateT cell populationsCourse of therapyLymphocyte countClinical responseLymphocyte populationsDisease progressionDiftitoxPatientsRegistration trialsHuman interleukinLactate dehydrogenaseSurvivalClinical Experience With Denileukin Diftitox (ONTAK)
Foss F. Clinical Experience With Denileukin Diftitox (ONTAK). Seminars In Oncology 2006, 33: 11-16. PMID: 16516670, DOI: 10.1053/j.seminoncol.2005.12.017.Peer-Reviewed Original ResearchConceptsIL-2 receptorCutaneous T-cell lymphomaT-cell lymphomaDenileukin diftitoxIntermediate affinity IL-2 receptorsHuman IL-2 receptorChronic lymphocytic leukemiaActivated T lymphocytesDiphtheria toxinClinical profileHodgkin's lymphomaHematologic disordersT lymphocytesLymphocytic leukemiaB cellsClinical experienceB lymphocytesLymphomaCytocidal actionNumber of leukemiasDiftitoxHigh affinity formCellular protein synthesisReceptorsLymphocytesImmunomodulatory Effects of Rexinoids
Foss F. Immunomodulatory Effects of Rexinoids. Seminars In Oncology 2006, 33: 21-25. PMID: 16516672, DOI: 10.1053/j.seminoncol.2005.12.019.Peer-Reviewed Original ResearchConceptsImmunomodulatory effectsCutaneous T-cell lymphomaReceptor-targeted therapyImproved clinical outcomesT-cell lymphomaPractical clinical approachExtracorporeal photophoresisClinical outcomesDenileukin diftitoxTherapy optionsHematologic malignanciesClinical activityPharmacotherapeutic agentsLymphoid malignanciesClinical approachTumor cellsRexinoidsMalignancyTreatmentDiftitoxLymphomaTherapy
2005
A phase-1 trial of bexarotene and denileukin diftitox in patients with relapsed or refractory cutaneous T-cell lymphoma
Foss F, Demierre MF, DiVenuti G. A phase-1 trial of bexarotene and denileukin diftitox in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2005, 106: 454-457. PMID: 15811959, DOI: 10.1182/blood-2004-11-4570.Peer-Reviewed Original ResearchConceptsRefractory cutaneous T-cell lymphomaCutaneous T-cell lymphomaPhase 1 trialT-cell lymphomaDenileukin diftitoxInterleukin-2High-affinity IL-2 receptorGrade 4 lymphopeniaLeukemia cellsIL-2R expressionIL-2 receptorT-cell leukemia cellsCD25 expressionIL-2RVivo upregulationP75 subunitDiftitoxGrade 2BexaroteneLow dosesPatientsLymphoma cellsBiomodulatory effectDiphtheria toxinLymphoma
2003
Interleukin-2 receptor–directed therapies for cutaneous lymphomas
Foss FM, Waldmann TA. Interleukin-2 receptor–directed therapies for cutaneous lymphomas. Hematology/Oncology Clinics Of North America 2003, 17: 1449-1458. PMID: 14710895, DOI: 10.1016/s0889-8588(03)00110-2.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalClinical Trials as TopicDiphtheria ToxinDrug Delivery SystemsGene Expression Regulation, NeoplasticHumansImmunoconjugatesImmunotherapyImmunotoxinsInterleukin-2Lymphoma, T-Cell, CutaneousNeoplasm ProteinsProtein IsoformsProtein SubunitsReceptors, Interleukin-2Recombinant Fusion ProteinsRetinoidsSkin NeoplasmsConceptsT-cell lymphomaIL-2RIL-2/IL-2R systemPeripheral T-cell lymphomaAnaplastic large cell lymphomaNatural killer lymphomaReceptor-directed therapyIL-2R systemIL-2 receptorLarge cell lymphomaRational therapeutic strategiesIL-2R subunitsCutaneous lymphomasSpecific immunotherapyIL-2Cell lymphomaTherapeutic strategiesLymphomaHumanized antibodyCTCLBeta-emitting radionuclidesAntibodiesImmunotherapyTherapyAgentsDenileukin Diftitox and Hyper-CVAD in the Treatment Human T-Cell Lymphotropic Virus 1–Associated Adult T-Cell Leukemia/Lymphoma
DiVenuti G, Nawgiri R, Foss F. Denileukin Diftitox and Hyper-CVAD in the Treatment Human T-Cell Lymphotropic Virus 1–Associated Adult T-Cell Leukemia/Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2003, 4: 176-178. PMID: 14715100, DOI: 10.3816/clm.2003.n.027.Peer-Reviewed Original ResearchConceptsAdult T-cell leukemia/lymphomaT-cell leukemia/lymphomaDenileukin diftitoxLeukemia/lymphomaClinical remissionHuman T-cell lymphotropic virus-1Human T-cell lymphotropic virusCell leukemia/lymphomaBone marrow myelofibrosisComplete clinical remissionBone marrow biopsyLymphotropic virus-1Acute T-cell leukemiaNormal hematopoiesisT-cell leukemiaLeukemic T cellsExtensive myelofibrosisHyper-CVADInitial therapyMaintenance therapyClinical improvementClinical manifestationsMarrow biopsyDisease progressionT cells
2002
Arginine butyrate increases the cytotoxicity of DAB389IL-2 in leukemia and lymphoma cells by upregulation of IL-2Rβ gene
Shao RH, Tian X, Gorgun G, Urbano AG, Foss FM. Arginine butyrate increases the cytotoxicity of DAB389IL-2 in leukemia and lymphoma cells by upregulation of IL-2Rβ gene. Leukemia Research 2002, 26: 1077-1083. PMID: 12443879, DOI: 10.1016/s0145-2126(02)00059-0.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsArginineButyratesCell SurvivalCyclic AMPDiphtheria ToxinDose-Response Relationship, DrugDrug SynergismHumansInterleukin-2Interleukin-2 Receptor beta SubunitLeukemiaLymphomaReceptors, InterleukinReceptors, Interleukin-2Recombinant Fusion ProteinsResponse ElementsSecond Messenger SystemsUp-RegulationConceptsCutaneous T-cell lymphomaIL-2R expressionNon-Hodgkin lymphomaArginine butyrateIL-2RLow affinity IL-2RHistone deacetylaseDirect growth-inhibitory effectB-cell non-Hodgkin lymphomaHigh-affinity IL-2 receptorLeukemia cellsCAMP response elementT-cell lymphomaIL-2 receptorNative diphtheria toxinGrowth inhibitory effectsClinical trialsP75 subunitAchievable concentrationsResponse rateVitro dataDAB389IL-2Interleukin-2 geneTumor cellsLymphoma cellsImmunomodulatory effects of RXR rexinoids: modulation of high-affinity IL-2R expression enhances susceptibility to denileukin diftitox
Gorgun G, Foss F. Immunomodulatory effects of RXR rexinoids: modulation of high-affinity IL-2R expression enhances susceptibility to denileukin diftitox. Blood 2002, 100: 1399-1403. PMID: 12149223, DOI: 10.1182/blood-2002-01-0300.Peer-Reviewed Original ResearchMeSH KeywordsAdjuvants, ImmunologicAlitretinoinAntineoplastic AgentsBexaroteneB-LymphocytesDiphtheria ToxinGene Expression RegulationHumansInterleukin-2Leukemia, Lymphocytic, Chronic, B-CellLeukemia-Lymphoma, Adult T-CellPrecursor B-Cell Lymphoblastic Leukemia-LymphomaReceptors, Interleukin-2Receptors, Retinoic AcidRecombinant Fusion ProteinsRetinoid X ReceptorsRetinoidsTetrahydronaphthalenesT-LymphocytesTranscription FactorsTretinoinTumor Cells, CulturedConceptsRetinoic acid receptorsImmunomodulatory effectsIL-2RHigh affinity IL-2R expressionCutaneous T-cell lymphomaHigh affinity IL-2R.Interleukin-2 receptor expressionIL-2R expressionT-cell lymphomaB cell leukemia cellsB-cell leukemiaT-cell leukemiaMechanism of actionAutoimmune diseasesHematologic malignanciesClinical activityReceptor expressionLymphoid malignanciesIL-2R.Retinoid X receptor (RXR) familyP75 subunitAcid receptorsRexinoid receptorsLeukemia cellsRexinoidsDiphtheria fusion protein therapy of chemoresistant malignancies.
Frankel AE, Rossi P, Kuzel TM, Foss F. Diphtheria fusion protein therapy of chemoresistant malignancies. Current Cancer Drug Targets 2002, 2: 19-36. PMID: 12188918, DOI: 10.2174/1568009023333944.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsClinical Trials as TopicDiphtheria ToxinDrug Resistance, NeoplasmHumansNeoplasmsRecombinant Fusion ProteinsConceptsTargeted toxinsFusion protein therapyDiphtheria toxinChemotherapy-refractory cancersSelective ligandsTumor-selective ligandsChemoresistant diseaseCombination chemotherapyNeoplastic stem cellsRefractory cancerChemoresistant malignancyGroup IPseudomonas exotoxinWidespread cancerTherapyCell functionCancer therapyAntiviral proteinProtein therapyCancerToxinQuality-of-Life Improvements in Cutaneous T-Cell Lymphoma Patients Treated with Denileukin Diftitox (ONTAK®)
Duvic M, Kuzel TM, Olsen EA, Martin AG, Foss FM, Kim YH, Heald PW, Bacha P, Nichols J, Liepa A. Quality-of-Life Improvements in Cutaneous T-Cell Lymphoma Patients Treated with Denileukin Diftitox (ONTAK®). Clinical Lymphoma Myeloma & Leukemia 2002, 2: 222-228. PMID: 11970761, DOI: 10.3816/clm.2002.n.003.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsDiphtheria ToxinDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfusions, IntravenousInterleukin-2Lymphoma, T-Cell, CutaneousMaleMiddle AgedNeoplasm StagingPatient SatisfactionProbabilityPrognosisProspective StudiesQuality of LifeRecombinant Fusion ProteinsReference ValuesRisk AssessmentSkin NeoplasmsStatistics, NonparametricTreatment OutcomeConceptsCutaneous T-cell lymphomaRecurrent cutaneous T-cell lymphomaDenileukin diftitoxPruritus severityOverall QoLSkin appearanceCutaneous T-cell lymphoma patientsAdverse transfusion-related eventsCancer Therapy-General (FACT-G) questionnaireT-cell lymphoma patientsPhase III trialsVascular leak syndromeT-cell lymphomaTransfusion-related eventsSignificant myelosuppressionIII trialsSkin severityStudy endpointLymphoma patientsOutpatient basisIndividual subscale scoresFunctional assessmentPatientsDiftitoxTreatment cycles