2019
A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors.
Chesney J, Lutzky J, Thomas S, Nieva J, Munoz Couselo E, Martin-Liberal J, Rodriguez-Moreno J, Cacovean A, Li H, Fardis M, Gettinger S. A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors. Journal Of Clinical Oncology 2019, 37: tps2648-tps2648. DOI: 10.1200/jco.2019.37.15_suppl.tps2648.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsPrior immune checkpoint inhibitorsObjective response rateTIL therapyAdoptive cell therapySystemic therapyCohort 1Cohort 3RECIST 1.1Metastatic melanomaNeck cancerPhase 2 multicenterPrior systemic therapyDurable complete responseOpen-label studyPhase II studyMetastatic melanoma patientsCo-primary endpointsHigh mutational burdenAutologous tumorECOG PSMeasurable diseaseAcceptable toxicityCheckpoint inhibitorsImmunogenic tumorsPhase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621.
Ratain M, Doi T, De Jonge M, LoRusso P, Dunbar M, Chiney M, Motwani M, Glasgow J, Petrich A, Rasco D, Calvo E. Phase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621. Journal Of Clinical Oncology 2019, 37: 3013-3013. DOI: 10.1200/jco.2019.37.15_suppl.3013.Peer-Reviewed Original ResearchDose escalationDose-limiting toxicityBlood-based markersECOG 0Prior regimensStable diseaseAcceptable toxicityMedian durationRespiratory failureMedian agePartial responseColorectal cancerPancreatic cancerBlood bilirubinBayesian continual reassessment methodPD markersContinual reassessment methodHuman studiesDay 1Solid tumorsTumor typesPK studiesTumor modelAntitumor activityApoptotic cell death
2015
Weekly ixabepilone with or without biweekly bevacizumab in the treatment of recurrent or persistent uterine and ovarian/primary peritoneal/fallopian tube cancers: A retrospective review
Roque DM, Ratner ES, Silasi DA, Azodi M, Rutherford TJ, Schwartz PE, Nelson WK, Santin AD. Weekly ixabepilone with or without biweekly bevacizumab in the treatment of recurrent or persistent uterine and ovarian/primary peritoneal/fallopian tube cancers: A retrospective review. Gynecologic Oncology 2015, 137: 392-400. PMID: 25792179, DOI: 10.1016/j.ygyno.2015.03.008.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalDrug Administration ScheduleEpothilonesFallopian Tube NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPeritoneal NeoplasmsProspective StudiesRetrospective StudiesConceptsObjective response rateFallopian tube cancerWeekly ixabepiloneOvarian cancerConcurrent bevacizumabRetrospective reviewMedian PFS/OSSimilar objective response ratesWarrants further prospective studySingle-institution retrospective reviewCA-125 criteriaPFS/OSTreatment of recurrentKaplan-Meier methodFurther prospective studiesBiweekly bevacizumabMedian PFSAcceptable toxicityGrade 1/2Median durationOverall survivalPrior linesClinical outcomesProspective studyUterine cancer
2013
HLA-Haploidentical Donor Lymphocyte Infusions for Patients with Relapsed Hematologic Malignancies after Related HLA-Haploidentical Bone Marrow Transplantation
Zeidan AM, Forde PM, Symons H, Chen A, Smith BD, Pratz K, Carraway H, Gladstone DE, Fuchs EJ, Luznik L, Jones RJ, Bolaños-Meade J. HLA-Haploidentical Donor Lymphocyte Infusions for Patients with Relapsed Hematologic Malignancies after Related HLA-Haploidentical Bone Marrow Transplantation. Transplantation And Cellular Therapy 2013, 20: 314-318. PMID: 24296490, PMCID: PMC4010132, DOI: 10.1016/j.bbmt.2013.11.020.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntineoplastic Agents, AlkylatingBone Marrow TransplantationChildChild, PreschoolCyclophosphamideFemaleGraft vs Host DiseaseHaplotypesHLA AntigensHumansLeukemia, Myeloid, AcuteLymphocyte TransfusionLymphomaMaleMiddle AgedRecurrenceRemission InductionSurvival AnalysisT-LymphocytesTransplantation ConditioningTransplantation, IsogeneicConceptsPost-transplantation cyclophosphamideDonor lymphocyte infusionBone marrow transplantationComplete responseLymphocyte infusionMarrow transplantationT-cell-replete bone marrow transplantationHLA-haploidentical bone marrow transplantationRelapsed hematologic malignanciesTreatment of relapseCells/Acute myeloid leukemiaAcute GVHDChronic GVHDAcceptable toxicityHost diseaseDurable responsesMedian durationMedian ageNonmyeloablative conditioningMedian timeEntire cohortHematologic malignanciesMyeloid leukemiaGrade 3
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 fungoides
2009
Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356)
Leichman L, Goldman B, Benedetti J, Billingsley K, Thomas C, Iqbal S, Lenz H, Blanke C, Gold P, Corless C. Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356). Journal Of Clinical Oncology 2009, 27: 4513-4513. DOI: 10.1200/jco.2009.27.15_suppl.4513.Peer-Reviewed Original ResearchExternal beam radiationPathologic complete responsePhase II trialOverall survivalEsophageal adenocarcinomaII trialSouthwest Oncology Group phase II trialGrade 3/4 toxicitiesMedian overall survivalNon-hematologic toxicitiesCentral pathology reviewPrimary tumor responseCooperative group trialsStandard of careTumor molecular profilesAcceptable toxicityFree survivalModality therapyComplete responseGastric cardiaNew regimensPathology reviewFuture trialsTumor responseSitu cancer
2007
Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy
Molife R, Cartwright T, Loesch D, Garbo L, Sonpavde G, Calvo E, Das A, Wanders J, Petrylak D, de Bono J. Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy. Journal Of Clinical Oncology 2007, 25: 15513-15513. DOI: 10.1200/jco.2007.25.18_suppl.15513.Peer-Reviewed Original ResearchHormone-refractory prostate cancerRefractory prostate cancerPSA responsePrior chemotherapyProstate cancerNon-small cell lung cancerSmall cell lung cancerPhase II multicenterRefractory breast cancerSerious adverse eventsSingle-agent activityCell lung cancerProstate cancer cell linesBolus IV infusionTwo-stage studyConcomitant steroidsCancer cell linesChest painFebrile neutropeniaStudy drugAcceptable toxicityMetastatic diseasePrior regimenRenal failureAdverse events
2000
Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point.
Small E, Lew D, Redman B, Petrylak D, Hammond N, Gross H, Eastham J, Crawford E. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. Journal Of Clinical Oncology 2000, 18: 2537-44. PMID: 10893284, DOI: 10.1200/jco.2000.18.13.2537.Peer-Reviewed Original ResearchConceptsAdvanced transitional cell carcinomaTransitional cell carcinomaCombination of paclitaxelSurvival timeMedian progression-free survival timeNeoadjuvant platinum-based therapySouthwest Oncology Group studyProgression-free survival timeClinical trial end pointsGrade 4 toxicityPoor prognostic featuresTrial end pointsEnrollment of patientsMedian survival timeOverall survival timeCooperative group settingPlatinum-based therapyResponse proportionsAcceptable toxicityExtranodal diseaseNeoadjuvant therapyNeurologic toxicityComplete responsePartial responsePrognostic features
1999
Adjuvant sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide (ATC) for high-risk breast cancer is feasible in the community setting.
Burtness B, Windsor S, Holston B, DiStasio S, Staugaard-Hahn C, Abrantes J, Kneuper-Hall R, Farber L, Orell J, Bober-Sorcinelli K, Haffty BG, Reiss M. Adjuvant sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide (ATC) for high-risk breast cancer is feasible in the community setting. The Cancer Journal 1999, 5: 224-9. PMID: 10439168.Peer-Reviewed Original ResearchConceptsBreast cancerDefinitive breast cancer surgeryMetastatic axillary lymph nodesHigh-risk breast cancerMore axillary nodesMyalgia/arthralgiaGrade 3 toxicityNausea/vomitingPercent of patientsAxillary lymph nodesHigh-risk patientsBreast cancer surgeryPreliminary efficacy dataFilgrastim supportNeutropenic feverAcceptable toxicityAdjuvant therapyAxillary nodesDose intensityStandard therapyBone scanLymph nodesCancer surgeryDistant metastasisAcute leukemia
1996
Stavudine (d4T, Zerit®)
Friedland G, Dunkle L, Cross A. Stavudine (d4T, Zerit®). Advances In Experimental Medicine And Biology 1996, 394: 271-277. PMID: 8815691, DOI: 10.1007/978-1-4757-9209-6_24.Peer-Reviewed Original ResearchConceptsAdvanced HIV-1 infectionEffects of stavudinePrior zidovudine therapyHIV-1 infectionImmunologic deteriorationAcceptable toxicityZidovudine therapyHIV diseaseClinical benefitSuch therapySurrogate markerClinical trialsDrug AdministrationStavudineTherapyBeneficial effectsU.S. FoodPatientsInfectionDiseaseAdministrationProgressionTrials
1990
Cyclophosphamide, carmustine, and etoposide with autologous bone marrow transplantation in refractory Hodgkin's disease and non-Hodgkin's lymphoma: a dose-finding study.
Wheeler C, Antin JH, Churchill WH, Come SE, Smith BR, Bubley GJ, Rosenthal DS, Rappaport JM, Ault KA, Schnipper LE. Cyclophosphamide, carmustine, and etoposide with autologous bone marrow transplantation in refractory Hodgkin's disease and non-Hodgkin's lymphoma: a dose-finding study. Journal Of Clinical Oncology 1990, 8: 648-56. PMID: 2313334, DOI: 10.1200/jco.1990.8.4.648.Peer-Reviewed Original ResearchConceptsAutologous bone marrow transplantationMaximum-tolerated doseBone marrow transplantationRelapsed lymphomaComplete responseMarrow transplantationDose levelsVP-16Refractory Hodgkin's diseaseTreatment-related mortalityDose-finding studyAssessable patientsAcceptable toxicityConditioning regimenInterstitial pneumonitisHodgkin's diseaseResidual diseaseHodgkin's lymphomaPatient populationDisease progressionHigh dosePatientsLymphomaDiseaseCBV
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