2023
Phase II trial of pembrolizumab in patients with brain metastases.
Brastianos P, Kim A, Giobbie-Hurder A, Lee E, Lin N, Overmoyer B, Wen P, Nayak L, Cohen J, Dietrich J, Heist R, Krop I, Lawrence D, Mayer E, Winer E, Shih H, Oh K, Cahill D, Gerstner E, Sullivan R. Phase II trial of pembrolizumab in patients with brain metastases. Journal Of Clinical Oncology 2023, 41: 2006-2006. DOI: 10.1200/jco.2023.41.16_suppl.2006.Peer-Reviewed Original ResearchBrain metastasesPrimary endpointBenefit rateEvaluable patientsLung cancerBreast cancerTherapeutic strategiesSingle-arm phase 2 clinical trialNon-small cell lung cancerHormone receptor-positive diseaseSmall cell lung cancerPhase 2 clinical trialGrade 4 toxicityLogical therapeutic strategyRECIST 1.1 criteriaMedian overall survivalPD-1 blockadePD-1 inhibitorsPrimary efficacy endpointReceptor-positive diseasePhase II trialImmune-based strategiesTriple-negative subtypeCell lung cancerT cell cytotoxicity
2017
TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM).
Freedman R, Gelman R, Melisko M, Anders C, Moy B, Blackwell K, Connolly R, Niravath P, Van Poznak C, Puhalla S, Farooq S, Cropp A, Cotter C, Liu M, Krop I, Nangia J, Tung N, Wolff A, Winer E, Lin N. TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM). Journal Of Clinical Oncology 2017, 35: 1005-1005. DOI: 10.1200/jco.2017.35.15_suppl.1005.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCombination of neratinibCentral nervous system (CNS) objective response rateCNS objective response rateNeurologic signs/symptomsGrade 3 toxicityGrade 4 toxicityMedian age 51Cancer brain metastasesPhase II trialSigns/symptomsEvidence-based treatmentsNon-CNS lesionsCNS progressionPrior lapatinibPrior WBRTPrimary endpointProtocol therapyBrain metastasesII trialCNS lesionsNew lesionsMedian numberBrain MRIPhase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients
Tolaney SM, Ziehr DR, Guo H, Ng MR, Barry WT, Higgins MJ, Isakoff SJ, Brock JE, Ivanova EV, Paweletz CP, Demeo MK, Ramaiya NH, Overmoyer BA, Jain RK, Winer EP, Duda DG. Phase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients. The Oncologist 2017, 22: 25-32. PMID: 27789775, PMCID: PMC5313267, DOI: 10.1634/theoncologist.2016-0229.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnilidesBiomarkers, TumorDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisPlacenta Growth FactorProtein Kinase InhibitorsProto-Oncogene Proteins c-metPyridinesTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor DVascular Endothelial Growth Factor Receptor-2ConceptsProgression-free survivalVascular endothelial growth factorBreast cancer patientsStable diseasePrimary endpointPartial responseCancer patientsBreast cancerMetastatic triple-negative breast cancer patientsMedian progression-free survivalSingle-arm phase IILonger progression-free survivalTriple-negative breast cancer patientsSoluble VEGF receptor 2Plasma placental growth factorTriple-negative breast cancerBiomarker studiesGrowth factorClinical benefit rateCytotoxic lymphocyte populationsGrade 4 toxicityObjective response ratePalmar-plantar erythrodysesthesiaSubset of patientsStromal cell-derived factor 1a
2016
ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL)
Grommes C, Gavrilovic I, Kaley T, Nolan C, Omuro A, Wolfe J, Pentsova E, Hatzoglou V, Mellinghoff I, DeAngelis L. ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL). Neuro-Oncology 2016, 18: vi3-vi4. DOI: 10.1093/neuonc/now212.011.Peer-Reviewed Original ResearchSecondary CNS lymphomaCNS lymphomaPhase I/II studyRecurrent/refractory diseaseAggressive primary brain tumorCerebrospinal fluid involvementCNS lymphoma patientsGrade 4 toxicityGrade 3 toxicityEnd-organ functionNormal end-organ functionSingle-agent ibrutinibPrimary brain tumorsPromising clinical responsesB-cell malignanciesCommon toxicitiesEligible patientsFungal encephalitisManageable toxicityMedian PFSMethotrexate regimensPrior therapySCNSL patientsClinical responseII study
2015
Phase I Study of Single Agent Ibrutinib in Recurrent/Refractory Primary and Secondary CNS Lymphoma
Christian G, Thomas K, Abdel-Wahab O, Omuro A, Ingo M, DeAngelis L. Phase I Study of Single Agent Ibrutinib in Recurrent/Refractory Primary and Secondary CNS Lymphoma. Blood 2015, 126: 3960. DOI: 10.1182/blood.v126.23.3960.3960.Peer-Reviewed Original ResearchRefractory primary CNS lymphomaPrimary CNS lymphomaSecondary CNS lymphomaDose level 2CNS lymphomaCommon grade 2 toxicityRecurrent primary CNS lymphomaRecurrent/refractory diseaseAggressive primary brain tumorCD20 antibody therapyCNS lymphoma patientsDose of ibrutinibGrade 4 toxicityPrior treatment regimensDose level 1Grade 2 toxicityGrade 3 toxicityMethotrexate-based chemotherapyEnd-organ functionNormal end-organ functionSingle-agent ibrutinibPhase I trialPrimary brain tumorsPromising clinical responsesAlternative therapeutic approach
2014
PHASE II TRIAL OF THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM
Wen P, Wen P, Yung W, Mellinghoff I, Ramkissoon S, Alexander B, Rinne M, Colman H, Omuro A, DeAngelis L, Gilbert M, DeGroot J, Cloughesy T, Lee E, Nayak L, S. A, Batchelor T, Chang S, Prados M, Reardon D, Ligon K. PHASE II TRIAL OF THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM. Neuro-Oncology 2014, 16: iii47-iii47. PMCID: PMC4144634, DOI: 10.1093/neuonc/nou209.20.Peer-Reviewed Original ResearchPI3K pathwayCohort 2Cohort 1Pan-class I PI3K inhibitorEnzyme-inducing antiepileptic drugsAdequate bone marrowGrade 4 toxicityGrowth of U87K pathwayGrade 3 toxicityPhase II studyPhase II trialRecurrent GBM patientsAdditional eligibility criteriaALT/ASTSingle-agent efficacyPotential therapeutic targetPI3K mutationsReduction of pAKTPI3K inhibitorsEvaluable patientsMedian OSMedian PFSPrior bevacizumabRadiologic progression
2009
Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assays
2008
Response to docetaxel/carboplatin‐based chemotherapy as first‐ and second‐line therapy in patients with metastatic hormone‐refractory prostate cancer
Nakabayashi M, Sartor O, Jacobus S, Regan M, McKearn D, Ross R, Kantoff P, Taplin M, Oh W. Response to docetaxel/carboplatin‐based chemotherapy as first‐ and second‐line therapy in patients with metastatic hormone‐refractory prostate cancer. BJU International 2008, 101: 308-312. PMID: 18184327, DOI: 10.1111/j.1464-410x.2007.07331.x.Peer-Reviewed Original ResearchConceptsHormone-refractory prostate cancerProstate-specific antigenSecond-lineProstate cancerMetastatic hormone-refractory prostate cancerProstate-specific antigen levelGrade 4 toxicityMedian overall survivalPatients treated with DCSecond-line chemotherapyFirst-line chemotherapySecond-line therapyDana-Farber Cancer InstituteCarboplatin AUCOverall survivalChemotherapyDana-FarberIdentified patientsDC groupDocetaxelCarboplatinPatientsCancer InstituteEstramustineRegimens
2007
Response to docetaxel (D)/carboplatin (C)-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer (HRPC)
Nakabayashi M, Sartor O, Jacobus S, Regan M, McKearn D, Ross R, Kantoff P, Taplin M, Oh W. Response to docetaxel (D)/carboplatin (C)-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2007, 25: 5156-5156. DOI: 10.1200/jco.2007.25.18_suppl.5156.Peer-Reviewed Original ResearchHormone-refractory prostate cancerMeasurable diseaseMedian survivalHormone-refractory prostate cancer patientsMetastatic hormone-refractory prostate cancerDuration of PSA responseGrade 4 toxicityPatients treated with DCSecond-line chemotherapyFirst-line chemotherapySecond-line therapyInitiation of chemotherapyKaplan-Meier methodEffective treatment optionAUC 4PSA declinePSA responseRECIST criteriaChemotherapy initiationMedian ageProstate cancerDC patientsTreatment optionsChemotherapyEvaluate efficacy
2006
Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial
Mayer E, Harris L, Partridge A, Gelman R, Schumer S, Comanaru R, Long M, Sampson E, Burstein H, Winer E. Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial. Journal Of Clinical Oncology 2006, 24: 10564-10564. DOI: 10.1200/jco.2006.24.18_suppl.10564.Peer-Reviewed Original ResearchMetastatic breast cancerMicroelectronic monitoring systemOral regimenValidation cohortDose reductionHand/foot syndromeSubstantial anti-tumor activityEGFR tyrosine kinase inhibitor gefitinibPhase IDose-escalation cohortsGrade 3 diarrheaGrade 4 toxicityCycles of therapyGrade 3 toxicityGrade 3/4 toxicitiesPhase I trialTyrosine kinase inhibitor gefitinibPost-therapy valuesMean numberCycle 1Lack of progressionAnti-tumor activityKinase inhibitor gefitinibEvaluable ptsUnresolved toxicityPhase 2 Study of the g209-2M Melanoma Peptide Vaccine and Low-Dose Interleukin-2 in Advanced Melanoma
Roberts JD, Niedzwiecki D, Carson WE, Chapman PB, Gajewski TF, Ernstoff MS, Hodi FS, Shea C, Leong SP, Johnson J, Zhang D, Houghton A, Haluska FG. Phase 2 Study of the g209-2M Melanoma Peptide Vaccine and Low-Dose Interleukin-2 in Advanced Melanoma. Journal Of Immunotherapy 2006, 29: 95-101. PMID: 16365605, DOI: 10.1097/01.cji.0000195295.74104.ad.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCancer VaccinesDose-Response Relationship, DrugFemalegp100 Melanoma AntigenHumansInterleukin-2Leukocytes, MononuclearMaleMelanomaMembrane GlycoproteinsMiddle AgedNeoplasm Recurrence, LocalPeptide FragmentsPeptidesSkin NeoplasmsConceptsLow-dose IL-2G209-2MG209-2M peptideHigh-dose IL-2Phase 2 studyAdvanced melanomaInterleukin-2T cellsHigh-dose interleukin-2Low-dose interleukin-2Melanoma tumor-infiltrating lymphocytesGrade 4 toxicityMelanoma peptide vaccineSubcutaneous IL-2Grade 2 toxicityGrade 3 toxicityTumor-infiltrating lymphocytesEnzyme-linked immunospotHuman leukocyte antigenDifferent toxicity profilesM peptideSignificant biologic effectsTetramer analysisToxic deathsMost patients
2004
Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma
Nanus DM, Garino A, Milowsky MI, Larkin M, Dutcher JP. Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma. Cancer 2004, 101: 1545-1551. PMID: 15378501, DOI: 10.1002/cncr.20541.Peer-Reviewed Original ResearchConceptsSarcomatoid renal cell carcinomaRenal cell carcinomaCell carcinomaAntitumor activityGemcitabine-based regimensGrade 4 toxicityModest antitumor activitySite of metastasisSite of diseaseCombination of doxorubicinInstitutional review boardStable diseaseMedian durationMedian survivalPartial responseRecurrent diseaseComplete responseActive chemotherapyFactor supportMedian timeDuct carcinomaProspective InvestigationInterleukin-2PatientsGemcitabine
2003
A Phase II study of estramustine, docetaxel, and carboplatin with granulocyte–colony‐stimulating factor support in patients with hormone‐refractory prostate carcinoma
Oh W, Halabi S, Kelly W, Werner C, Godley P, Vogelzang N, Small E, B F. A Phase II study of estramustine, docetaxel, and carboplatin with granulocyte–colony‐stimulating factor support in patients with hormone‐refractory prostate carcinoma. Cancer 2003, 98: 2592-2598. PMID: 14669278, DOI: 10.1002/cncr.11829.Peer-Reviewed Original ResearchConceptsGranulocyte-colony-stimulating factorHormone-refractory prostate carcinomaPretreatment prostate-specific antigenGranulocyte-colony-stimulating factor supportProstate carcinomaMedian time to disease progressionTime to disease progressionAdvanced prostatic carcinomaCombination of estramustineAndrogen deprivation therapyGrade 4 toxicityCycles of therapyPhase II studyProstate-specific antigenOverall survival periodCooperative group studiesComplete responseDeprivation therapyFebrile neutropeniaPartial responseFactor supportToxicity profileGrade 3DocetaxelCarboplatin
2001
A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer
Kim E, Lu C, Khuri F, Tonda M, Glisson B, Liu D, Jung M, Hong W, Herbst R. A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer. Lung Cancer 2001, 34: 427-432. PMID: 11714540, DOI: 10.1016/s0169-5002(01)00278-1.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPhase II studyPlatinum-based chemotherapyCell lung cancerII studyLung cancerStage IV non-small cell lung cancerAdvanced non-small cell lung cancerGrade 3 nonhematological toxicitiesMedian Karnofsky performance statusPrior platinum-based chemotherapyPhase ICisplatin-based regimensPrior chemotherapy regimensGrade 4 toxicityKarnofsky performance statusPopulation of patientsDose-related toxicityNonhematological toxicitiesStable diseaseChemotherapy regimensRenal insufficiencyStage IIIBMedian survivalPerformance statusClinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.
Burstein H, Kuter I, Campos S, Gelman R, Tribou L, Parker L, Manola J, Younger J, Matulonis U, Bunnell C, Partridge A, Richardson P, Clarke K, Shulman L, Winer E. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2001, 19: 2722-30. PMID: 11352965, DOI: 10.1200/jco.2001.19.10.2722.Peer-Reviewed Original ResearchConceptsGrade 2 cardiac toxicityAdvanced breast cancerBreast cancerResponse rateCardiac toxicityHER2-overexpressing metastatic breast cancerOnly grade 4 toxicityHER2-positive breast cancerCumulative doxorubicin doseGrade 4 toxicityStudy of trastuzumabSymptomatic heart failureThird-line therapyFirst-line therapyType of chemotherapyMetastatic breast cancerPercent of womenHigh response rateConcurrent trastuzumabPrior chemotherapyWeekly vinorelbineMetastatic diseasePositive patientsHeart failureDoxorubicin dose
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 featuresDocetaxel administered on a weekly basis for metastatic breast cancer.
Burstein H, Manola J, Younger J, Parker L, Bunnell C, Scheib R, Matulonis U, Garber J, Clarke K, Shulman L, Winer E. Docetaxel administered on a weekly basis for metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 1212-9. PMID: 10715290, DOI: 10.1200/jco.2000.18.6.1212.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerWeekly docetaxelBreast cancerPrior chemotherapyCumulative docetaxel doseGrade 4 toxicityGrade 3 toxicityPercent of patientsWeeks of therapySide effect profileSubgroup of patientsSimilar response ratesAdjuvant chemotherapyDocetaxel doseStable diseasePartial responseComplete responseTreat analysisTreatment breaksEffect profileFluid retentionPatient preferencesDisease progressionRepetitive dosingDose reductionAndrogen deprivation and four courses of fixed-schedule suramin treatment in patients with newly diagnosed metastatic prostate cancer: A Southwest Oncology Group Study.
Hussain M, Fisher E, Petrylak D, O’Connor J, Wood D, Small E, Eisenberger M, Crawford E. Androgen deprivation and four courses of fixed-schedule suramin treatment in patients with newly diagnosed metastatic prostate cancer: A Southwest Oncology Group Study. Journal Of Clinical Oncology 2000, 18: 1043-9. PMID: 10694555, DOI: 10.1200/jco.2000.18.5.1043.Peer-Reviewed Original ResearchConceptsMetastatic prostate cancerAndrogen deprivationProstate cancerTreatment interruptionGrade 3Southwest Oncology Group studyCombination of suraminTherapy-related deathsGrade 4 toxicityCooperative group settingTreatment of patientsNumber of patientsFeasibility of treatmentAdequate hematologicOverall survivalCoagulation parametersDisease progressionSuramin treatmentPatientsSecond courseTreatment cyclesMultiple coursesCancerSuraminSuch treatment
1999
Intermediate‐dose intravenous melphalan and blood stem cells mobilized with sequential GM+G‐CSF or G‐CSF alone to treat AL (amyloid light chain) amyloidosis
COMENZO R, SANCHORAWALA V, FISHER C, AKPEK G, FARHAT M, CERDA S, BERK J, DEMBER L, FALK R, FINN K, SKINNER M, VOSBURGH E. Intermediate‐dose intravenous melphalan and blood stem cells mobilized with sequential GM+G‐CSF or G‐CSF alone to treat AL (amyloid light chain) amyloidosis. British Journal Of Haematology 1999, 104: 553-559. PMID: 10086794, DOI: 10.1046/j.1365-2141.1999.01216.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAmyloidosisAntineoplastic Agents, AlkylatingDrug CombinationsFemaleGranulocyte Colony-Stimulating FactorGranulocyte-Macrophage Colony-Stimulating FactorHematopoietic Stem Cell MobilizationHematopoietic Stem Cell TransplantationHumansInfusions, IntravenousLeukapheresisMaleMelphalanMiddle AgedSurvival AnalysisConceptsBlood stem cellsMobilization regimensG-CSFIntermediate dose (15-30 mg/m2, day 1) intravenous melphalanDose-intensive melphalanPhase 11 trialGrade 4 toxicityComplete haematological responseCells/AL amyloidosis patientsTerms of CD34Stem cellsActive regimenMobilization patientsDose melphalanOrgan involvementIntravenous melphalanCardiac amyloidD mortalityMonths 57AL amyloidosisAmyloidosis patientsHaematological responsePatientsDay 5
1998
Daily Oral Etoposide in Patients With Heavily Pretreated Metastatic Breast Cancer
Pusztai L, Walters R, Valero V, Theriault R, Hortobagyi G. Daily Oral Etoposide in Patients With Heavily Pretreated Metastatic Breast Cancer. American Journal Of Clinical Oncology 1998, 21: 442-446. PMID: 9781596, DOI: 10.1097/00000421-199810000-00004.Peer-Reviewed Original ResearchConceptsGrade 4 toxicityMetastatic breast cancerSignificant hematologic toxicityOral etoposideBreast cancerGrade 2Hematologic toxicityDaily oral etoposideFourth-line agentZubrod performance statusPercent of patientsPhase II studyMajority of patientsGreater thrombocytopeniaNeutropenic feverStable diseasePrevious therapyRadiologic evidenceII studyMedian durationPartial responsePerformance statusMedian ageMore regimensSevere anemia
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