2019
Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study.
Khodadoust MS, Rook AH, Porcu P, Foss F, Moskowitz AJ, Shustov A, Shanbhag S, Sokol L, Fling SP, Ramchurren N, Pierce R, Davis A, Shine R, Li S, Fong S, Kim J, Yang Y, Blumenschein WM, Yearley JH, Das B, Patidar R, Datta V, Cantu E, McCutcheon JN, Karlovich C, Williams PM, Subrahmanyam PB, Maecker HT, Horwitz SM, Sharon E, Kohrt HE, Cheever MA, Kim YH. Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study. Journal Of Clinical Oncology 2019, 38: 20-28. PMID: 31532724, PMCID: PMC6943974, DOI: 10.1200/jco.19.01056.Peer-Reviewed Original ResearchConceptsRefractory mycosis fungoidesSézary syndromeOverall response rateMycosis fungoidesTreatment discontinuationFlare reactionAdvanced MF/SSResponse rateMF/Sézary syndromeMulticenter phase II studyMulticenter phase II trialSeverity-Weighted Assessment ToolHigh PD-1 expressionAdvanced mycosis fungoidesEfficacy of pembrolizumabPrior systemic therapySubsequent clinical responseAdvanced-stage diseasePhase II studyPrimary end pointPD-1 expressionPhase II trialFavorable safety profileTotal mutation burdenLack of response
2018
A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma
Foss FM, Parker T. A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma. The Oncologist 2018, 23: 397-e30. PMID: 29438091, PMCID: PMC5896711, DOI: 10.1634/theoncologist.2017-0658.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaOverall response rateIntermediate-grade B-cellB cellsPartial responseResponse ratePhase I dose-escalation studyRefractory acute lymphoblastic leukemiaI dose-escalation studyT-cell non-Hodgkin lymphomaB-cell non-Hodgkin lymphomaPositron emission tomography scanSecond-generation purine nucleoside analogAggressive B-cell lymphomasPhase IDose of clofarabineGrade 3 leukopeniaLow-dose cohortMinimal hematologic toxicityRefractory acute leukemiaRefractory low gradeRefractory lymphoid malignanciesSingle-agent rituximab
2016
Infusion reactions are common after high-dose carmustine in BEAM chemotherapy and are not reduced by lengthening the time of administration
Perreault S, Baker J, Medoff E, Pratt K, Foss F, Isufi I, Seropian S, Cooper DL. Infusion reactions are common after high-dose carmustine in BEAM chemotherapy and are not reduced by lengthening the time of administration. Supportive Care In Cancer 2016, 25: 205-208. PMID: 27614867, DOI: 10.1007/s00520-016-3399-4.Peer-Reviewed Original ResearchAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarmustineCytarabineDose-Response Relationship, DrugDrug Administration ScheduleEtoposideFemaleHematopoietic Stem Cell TransplantationHumansInfusions, IntravenousMaleMelphalanMiddle AgedTransplantation ConditioningTransplantation, AutologousYoung AdultRomidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. Journal Of Hematology & Oncology 2016, 9: 22. PMID: 26965915, PMCID: PMC4785666, DOI: 10.1186/s13045-016-0243-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDisease ProgressionDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedNauseaNeoplasm Recurrence, LocalNeutropeniaRemission InductionTime FactorsTreatment OutcomeYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaStable diseaseT-cell lymphomaClinical benefitPivotal trialsCell lymphomaDay 1Good responseLong stable diseaseObjective response rateProgression-free survivalUnconfirmed complete responseT-cell malignanciesHistone deacetylase inhibitorsProlonged dosingDurable responsesMedian durationObjective responsePartial responseComplete responseCurrent therapiesProtocol amendmentCell malignanciesPatients
2015
Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study
O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. Journal Of Clinical Oncology 2015, 33: 2492-2499. PMID: 26101246, PMCID: PMC5087312, DOI: 10.1200/jco.2014.59.2782.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalSulfonamidesTreatment OutcomeConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaInternational Working Group criteriaOverall response rateT-cell lymphomaPrior therapyOverall survivalGroup criteriaResponse rateEnd pointCommon grade 3Prior systemic therapyPrimary end pointSecondary end pointsNovel histone deacetylase inhibitorStem cell transplantationDuration of responseStandard of careDrug Administration approvalHistone deacetylase inhibitorsEvaluable patientsManageable toxicityAdverse eventsDurable responsesPartial responsePhase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma
Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood 2015, 125: 1883-1889. PMID: 25605368, PMCID: PMC4375715, DOI: 10.1182/blood-2014-09-600924.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaEfficacy of mogamulizumabT-cell lymphomaAnti-CC chemokine receptor 4 monoclonal antibodyFrequent treatment-emergent adverse eventsCutaneous T-cell lymphoma patientsTreatment-emergent adverse eventsT-cell lymphoma patientsSignificant hematologic effectsInfusion-related reactionsPhase 1/2 studyOverall response ratePhase 3 investigationAnti-CCR4 antibodyEvaluable patientsBlood involvementAdverse eventsGrade 1/2Sézary syndromeComplete responseMycosis fungoidesLymphoma patientsHematologic effectsDisease progressionMogamulizumab
2014
A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma
Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben‐Yehuda D, Beylot‐Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma. British Journal Of Haematology 2014, 168: 811-819. PMID: 25404094, DOI: 10.1111/bjh.13222.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm StagingRecurrenceSulfonamidesTreatment OutcomeYoung AdultConceptsCutaneous T-cell lymphomaPeripheral T-cell lymphomaObjective response rateT-cell lymphomaPrior systemic therapyStage IV diseaseSystemic therapyAdverse eventsTreatment-related serious adverse eventsRefractory peripheral T-cell lymphomaTreatment-related adverse eventsPan-histone deacetylase inhibitorInfusion site painSkin-directed therapiesGrade 4 thrombocytopeniaSerious adverse eventsPhase II trialJugular vein thrombosisAnti-angiogenic propertiesOpen labelII trialParalytic ileusPeripheral edemaPrimary endpointSite painRomidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. Journal Of Hematology & Oncology 2014, 7: 11. PMID: 24456586, PMCID: PMC4016573, DOI: 10.1186/1756-8722-7-11.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticCellulitisDepsipeptidesDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansInfusions, IntravenousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRemission InductionTime FactorsTreatment OutcomeVenous ThrombosisVomitingConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaCR/CRuDuration of responseObjective response rateT-cell lymphomaDurable responsesPrior therapySystemic therapyMedian DORMedian progression-free survivalCutaneous T-cell lymphomaReported safety profileProgression-free survivalUnconfirmed complete responseSubset of patientsLong-term responseIndependent review committeeTreatment of patientsSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsLack of responseHeavy pretreatmentStable diseasePrimary endpoint
2012
Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma
Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2012, 119: 4115-4122. PMID: 22394596, DOI: 10.1182/blood-2011-11-390211.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopterinAntimetabolites, AntineoplasticDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleDrug EruptionsFatigueFemaleGastrointestinal DiseasesHumansLymphoma, T-Cell, CutaneousMaleMiddle AgedMucositisNeutropeniaSalvage TherapySkin NeoplasmsThrombocytopeniaConceptsCutaneous T-cell lymphomaRefractory cutaneous T-cell lymphomaT-cell lymphomaAdverse eventsSystemic therapyPrimary cutaneous anaplastic large cell lymphomaCommon grade 3 adverse eventsOnly grade 4 adverse eventCutaneous anaplastic large cell lymphomaGrade 3 adverse eventsGrade 4 adverse eventsAnaplastic large cell lymphomaPrior systemic therapyAcceptable toxicity profileLong-term dosingLarge cell lymphomaFolate carrier 1De-escalation strategiesAcceptable toxicityExpansion cohortStarting doseSézary syndromeSystemic treatmentDosing regimenMycosis fungoidesResults From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy. Journal Of Clinical Oncology 2012, 30: 631-636. PMID: 22271479, DOI: 10.1200/jco.2011.37.4223.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDiarrheaDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalPneumoniaTreatment OutcomeVascular DiseasesVomitingYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaPrior systemic therapyCR/CRuSystemic therapyT-cell lymphomaPrior therapyComplete response/unconfirmed complete responseResponse ratePrior stem cell transplantationEfficacy of romidepsinSingle-agent romidepsinObjective response ratePhase II studyPrimary end pointPhase II trialUnconfirmed complete responseStem cell transplantationIndependent review committeeDrug Administration approvalSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsManageable toxicityII trialOpen label
2007
Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma
Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2007, 25: 3109-3115. PMID: 17577020, DOI: 10.1200/jco.2006.10.2434.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansHydroxamic AcidsLymphoma, T-Cell, CutaneousMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingProbabilitySalvage TherapySkin NeoplasmsSurvival AnalysisTreatment OutcomeVorinostatConceptsObjective response rateDuration of responseMF/SSStage IIBAdverse experiencesOral vorinostatPruritus reliefHigh patientCommon drug-related adverse experiencesRefractory cutaneous T-cell lymphomaMedian DORDrug-related adverse experiencesCutaneous T-cell lymphomaEnd pointT-cell lymphoma subtypesPrior systemic therapyStage IIB diseasePrimary end pointSecondary end pointsAcceptable safety profileHistone deacetylase inhibitor vorinostatPhase IIb trialT-cell lymphomaRecurrent mycosis fungoidesIIB disease
2006
Efficacy of low dose clofarabine in refractory precursor T- acute lymphoblastic leukemia.
Choi J, Foss F. Efficacy of low dose clofarabine in refractory precursor T- acute lymphoblastic leukemia. The Yale Journal Of Biology And Medicine 2006, 79: 169-72. PMID: 17940627, PMCID: PMC1994805.Peer-Reviewed Original ResearchMeSH KeywordsAdenine NucleotidesAdultArabinonucleosidesBone Marrow NeoplasmsClinical Trials as TopicClofarabineDrug Administration ScheduleDrug Resistance, NeoplasmHumansImmunophenotypingLeukemia-Lymphoma, Adult T-CellMaleRecurrenceSkin NeoplasmsStem Cell TransplantationTransplantation, HomologousTreatment OutcomeConceptsLow dose clofarabineLymphoblastic leukemiaAllogeneic stem cell transplantationSignificant clinical activityStem cell transplantationNear complete responseAcute lymphoblastic leukemiaPediatric B-ALLT-cell leukemiaAllogeneic transplantsComplete responsePoor prognosisCell transplantationB-ALLPrecursor TClinical activityNew agentsNovel nucleoside analogueClofarabinePatientsLeukemiaNucleoside analoguesSignificant activityRemissionTransplantationA phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides
Duvic M, Sherman ML, Wood GS, Kuzel TM, Olsen E, Foss F, Laliberté RJ, Ryan JL, Zonno K, Rook AH. A phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides. Journal Of The American Academy Of Dermatology 2006, 55: 807-813. PMID: 17052486, DOI: 10.1016/j.jaad.2006.06.038.Peer-Reviewed Original ResearchConceptsSeverity-weighted assessment toolMonths of therapyPartial responseRhIL-12Mycosis fungoidesAdverse eventsInterleukin-12Phase II open-label studyDuration of PROpen-label clinical trialTreatment-related adverse eventsRecombinant human IL-12Recombinant human interleukin-12Early-stage MFIIA mycosis fungoidesRhIL-12 treatmentOpen-label studyAlanine aminotransferase levelsLabel clinical trialInjection site reactionsNatural killer cellsT cell activityEarly mycosis fungoidesT helper cellsHuman IL-12
2002
A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96
Bailey HH, Levy D, Harris LS, Schink JC, Foss F, Beatty P, Wadler S. A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96. Gynecologic Oncology 2002, 85: 464-468. PMID: 12051875, DOI: 10.1006/gyno.2002.6647.Peer-Reviewed Original ResearchConceptsProgression-free rateAdvanced ovarian cancerOvarian cancerPerillyl alcoholMedian progression-free survivalPrior platinum-based therapyAdvanced ovarian carcinomaMedian overall survivalObjective response ratePhase II studyPhase II trialProgression-free survivalLDL cholesterol levelsPlatinum-based therapyGastrointestinal toxicityII trialPrimary endpointRecurrent diseaseUnacceptable toxicityII studyOverall survivalPartial responseHistoric controlsCholesterol levelsOvarian carcinomaQuality-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