2020
Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome
Holkova B, Shafer D, Yazbeck V, Dave S, Bose P, Tombes MB, Shrader E, Wan W, Bandyopadhyay D, Weir C, Collins EB, Garnett A, Kmieciak M, Roberts JD, Garcia-Manero G, Grant S. Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome. Leukemia & Lymphoma 2020, 62: 1187-1194. PMID: 33356689, PMCID: PMC8106643, DOI: 10.1080/10428194.2020.1861270.Peer-Reviewed Original ResearchConceptsStable diseaseAcute leukemiaDay 1Phase 1 dose-escalation studyRefractory acute leukemiaDose-escalation studyPhase 1 studyWhole-exome sequencingComplete pathologicKaryotypic responseAdult patientsQTc prolongationFirst patientMyelodysplastic syndromeTreatment strategiesBlast crisisPatientsExceptional responseKaryotypic aberrationsBelinostatGood responseBortezomibAMLLeukemiaFurther investigation
2017
A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma
Holkova B, Yazbeck V, Kmieciak M, Bose P, Ma S, Kimball A, Tombes MB, Shrader E, Wan W, Weir-Wiggins C, Singh A, Hogan KT, Conine S, Sankala H, Roberts JD, Shea TC, Grant S. A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leukemia & Lymphoma 2017, 58: 1349-1357. PMID: 28103725, PMCID: PMC5817887, DOI: 10.1080/10428194.2016.1276287.Peer-Reviewed Original ResearchConceptsT-cell lymphomaMaximum-tolerated doseDose-limiting toxicityPhase 1 studyStable diseaseChronic lymphocytic leukemia/small lymphocytic lymphomaRefractory CLL/SLLPeripheral T-cell lymphomaCutaneous T-cell lymphomaIndolent B-cell lymphomaGrade 3 fatigueMedian treatment durationCLL/SLLSingle-agent bortezomibSmall lymphocytic lymphomaExpression of NFB-cell lymphomaRefractory CLLMedian durationPartial responseProgressive diseaseSafety profileLymphocytic lymphomaTreatment durationDay 1
2016
Phase I study of pemetrexed with sorafenib in advanced solid tumors
Poklepovic A, Gordon S, Shafer DA, Roberts JD, Bose P, Geyer CE, McGuire WP, Tombes MB, Shrader E, Strickler K, Quigley M, Wan W, Kmieciak M, Massey HD, Booth L, Moran RG, Dent P. Phase I study of pemetrexed with sorafenib in advanced solid tumors. Oncotarget 2016, 7: 42625-42638. PMID: 27213589, PMCID: PMC5173162, DOI: 10.18632/oncotarget.9434.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCohort StudiesFemaleHumansInflammationMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNiacinamidePemetrexedPhenylurea CompoundsPTEN PhosphohydrolaseSorafenibTreatment OutcomeTriple Negative Breast NeoplasmsConceptsAdvanced solid tumorsDay 1Solid tumorsOral sorafenibDose scheduleBreast cancerTriple-negative breast cancerDose-escalation schemaPhase II dosePhase I trialSorafenib dosingSorafenib therapyStable diseaseCohort BComplete responseI trialPartial responseTolerable combinationRadiographic assessmentCumulative toxicityCombination treatmentPatientsSorafenibPhase IAntitumor activity
2015
Phase II trial of dasatinib for recurrent or metastatic c-KIT expressing adenoid cystic carcinoma and for nonadenoid cystic malignant salivary tumors
Wong SJ, Karrison T, Hayes DN, Kies MS, Cullen KJ, Tanvetyanon T, Argiris A, Takebe N, Lim D, Saba NF, Worden FP, Gilbert J, Lenz HJ, Razak AR, Roberts JD, Vokes EE, Cohen EE. Phase II trial of dasatinib for recurrent or metastatic c-KIT expressing adenoid cystic carcinoma and for nonadenoid cystic malignant salivary tumors. Annals Of Oncology 2015, 27: 318-323. PMID: 26598548, PMCID: PMC4722891, DOI: 10.1093/annonc/mdv537.Peer-Reviewed Original ResearchConceptsMalignant salivary gland tumorsAdverse eventsStable diseaseObjective responseACC patientsCystic carcinomaECOG performance status 0Grade 3 adverse eventsMedian age 56 yearsGrade 4 adverse eventsMedian progression-free survivalFrequent adverse eventsMedian overall survivalNon-ACC patientsPerformance status 0Noncardiac chest painPhase II studyPhase II trialProgression-free survivalAge 56 yearsMalignant salivary tumorsAdenoid cystic carcinomaSalivary gland tumorsCycle 2Prior chemotherapyDaily home opioid use in adults with sickle cell disease: The PiSCES project.
Smith WR, McClish DK, Dahman BA, Levenson JL, Aisiku IP, de A Citero V, Bovbjerg VE, Roberts JD, Penberthy LT, Roseff SD. Daily home opioid use in adults with sickle cell disease: The PiSCES project. Journal Of Opioid Management 2015, 11: 243-53. PMID: 25985809, DOI: 10.5055/jom.2015.0273.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAdaptation, PsychologicalAdolescentAdultAnalgesics, OpioidAnemia, Sickle CellAntisickling AgentsCost of IllnessDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansHydroxyureaLongitudinal StudiesMaleMiddle AgedPainPain MeasurementQuality of LifeSelf AdministrationTime FactorsTreatment OutcomeYoung AdultConceptsSickle cell diseaseHome opioid useOpioid usePain daysOpioid usersMean painCell diseasePsychosocial variablesDaily pain diaryMajority of patientsNon-opioid analgesicsSomatic symptom burdenPiSCES projectOpioid prescribingPain frequencyCohort studySymptom burdenPain diaryPain intensityPatient characteristicsPhysical QoLOpioidsPatientsSCD samplesSimilar association
2014
Phase I Trial of Bortezomib (PS-341; NSC 681239) and “Nonhybrid” (Bolus) Infusion Schedule of Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-cell Neoplasms
Holkova B, Kmieciak M, Perkins EB, Bose P, Baz RC, Roodman GD, Stuart RK, Ramakrishnan V, Wan W, Peer CJ, Dawson J, Kang L, Honeycutt C, Tombes MB, Shrader E, Weir-Wiggins C, Wellons M, Sankala H, Hogan KT, Colevas AD, Doyle LA, Figg WD, Coppola D, Roberts JD, Sullivan D, Grant S. Phase I Trial of Bortezomib (PS-341; NSC 681239) and “Nonhybrid” (Bolus) Infusion Schedule of Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-cell Neoplasms. Clinical Cancer Research 2014, 20: 5652-5662. PMID: 25248382, PMCID: PMC4233160, DOI: 10.1158/1078-0432.ccr-14-0805.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityCombination of bortezomibCommon hematologic toxicityCommon nonhematologic toxicitiesIndolent B-cell neoplasmsRefractory multiple myelomaDose-escalation designNon-Hodgkin lymphomaTotal response rateB-cell malignanciesB-cell neoplasmsPharmacodynamic study resultsNonhematologic toxicitySchedule regimenStable diseaseComplete remissionHematologic toxicityPartial remissionClinical responseInvestigator's discretionDosing regimenI trialPharmacokinetic findingsSensory neuropathyInfusion schedule
2013
A Phase I Trial of Vorinostat and Alvocidib in Patients with Relapsed, Refractory, or Poor Prognosis Acute Leukemia, or Refractory Anemia with Excess Blasts-2
Holkova B, Supko JG, Ames MM, Reid JM, Shapiro GI, Perkins EB, Ramakrishnan V, Tombes MB, Honeycutt C, McGovern RM, Kmieciak M, Shrader E, Wellons MD, Sankala H, Doyle A, Wright J, Roberts JD, Grant S. A Phase I Trial of Vorinostat and Alvocidib in Patients with Relapsed, Refractory, or Poor Prognosis Acute Leukemia, or Refractory Anemia with Excess Blasts-2. Clinical Cancer Research 2013, 19: 1873-1883. PMID: 23515411, PMCID: PMC3618599, DOI: 10.1158/1078-0432.ccr-12-2926.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdultAgedAnemia, Refractory, with Excess of BlastsAntineoplastic Combined Chemotherapy ProtocolsCell Line, TumorCyclin-Dependent Kinase Inhibitor p21FemaleFlavonoidsHumansHydroxamic AcidsLeukemiaMaleMaximum Tolerated DoseMiddle AgedMyeloid Cell Leukemia Sequence 1 ProteinPiperidinesPrognosisProto-Oncogene Proteins c-bcl-2RecurrenceRNA Polymerase IITreatment OutcomeVorinostatYoung AdultConceptsMaximum-tolerated dosePoor-prognosis acute leukemiaExcess blasts-2Objective responseQT prolongationAcute leukemiaBlasts-2Phase I trialBone marrow responseCardiac arrhythmia atrial fibrillationArrhythmia atrial fibrillationEvaluable patientsStable diseaseVorinostat pharmacokineticsDisease stabilizationMaintenance infusionI trialMarrow responsePharmacodynamic effectsRefractory anemiaIntravenous infusionLoading infusionPatientsVorinostatSecondary objectivePhase I trial of bortezomib and dacarbazine in melanoma and soft tissue sarcoma
Poklepovic A, Youseffian L, Winning M, Birdsell CA, Crosby NA, Ramakrishnan V, Ernstoff MS, Roberts JD. Phase I trial of bortezomib and dacarbazine in melanoma and soft tissue sarcoma. Investigational New Drugs 2013, 31: 937-942. PMID: 23315028, PMCID: PMC3844155, DOI: 10.1007/s10637-012-9913-8.Peer-Reviewed Original ResearchConceptsSoft tissue sarcomasPhase I trialTissue sarcomasPartial responseI trialPhase II dosesDurable complete responseAmine precursor uptakeTwenty-eight patientsProteasome inhibitor bortezomibHuman melanoma cell linesMurine xenograft tumor modelXenograft tumor modelCKIT mutationsDecarboxylation (APUD) tumorsProphylactic antiemeticsRECIST v1.0Eight patientsComplete responseMelanoma cell linesWeekly dosesDose escalationAgent dacarbazinePreclinical studiesDose levels
2011
Phase II Trials Powered to Detect Tumor Subtypes
Roberts JD, Ramakrishnan V. Phase II Trials Powered to Detect Tumor Subtypes. Clinical Cancer Research 2011, 17: 5538-5545. PMID: 21737510, DOI: 10.1158/1078-0432.ccr-10-2466.Peer-Reviewed Original ResearchConceptsTumor subtypesResponse ratePhase II trial designPhase II trialPhase III trialsOverall response ratePhase II designStage 1Characterization of tumorsII trialIII trialsMetastatic diseaseSimilar patientsProspective characterizationSample sizeTrial designSubtypesTumorsTotal sample sizePhase IIII designTrialsTreatmentVariables of interestDifferent treatments
2007
Patient satisfaction in specialized versus nonspecialized adult sickle cell care centers: the PiSCES study.
Aisiku IP, Penberthy LT, Smith WR, Bovbjerg VE, McClish DK, Levenson JL, Roberts JD, Roseff SD. Patient satisfaction in specialized versus nonspecialized adult sickle cell care centers: the PiSCES study. Journal Of The National Medical Association 2007, 99: 886-90. PMID: 17722665, PMCID: PMC2574305.Peer-Reviewed Original ResearchConceptsNonspecialized centersPatient satisfactionSpecialized centersSCD careSCD patientsCare centerInterpersonal mannerSatisfaction scoresHighest mean satisfaction scoreSickle cell disease patientsProspective cohort studyGeneral satisfactionPatient satisfaction surveyMean satisfaction scoreQuality of careHigher satisfaction scoresSatisfaction surveySCD specialistsCohort studySignificant group differencesPotential confoundersDisease patientsAmbulatory carePatientsPractice style
2002
Higher doses of mitoxantrone among men with hormone‐refractory prostate carcinoma
Levine EG, Halabi S, Roberts JD, Kaplan EB, Rago R, Atkins JN, Vogelzang NJ. Higher doses of mitoxantrone among men with hormone‐refractory prostate carcinoma. Cancer 2002, 94: 665-672. PMID: 11857298, DOI: 10.1002/cncr.10217.Peer-Reviewed Original ResearchConceptsHormone-refractory prostate carcinomaHigh dosesPelvic irradiationProstate carcinomaArm IFrequency of thrombocytopeniaLow-dose glucocorticoidsArm IIPhase II trialPhase III trialsPhase III testingMedian survival timeGranulocyte-macrophage colony-stimulating factorColony-stimulating factorAssessable patientsEstramustine combinationsII trialIII trialsMedian survivalPartial responsePSA valuesFavorable outcomeSurvival timePatientsSame schedule
1999
Leucovorin, 5-fluorouracil, and gemcitabine: A phase I study
Poplin E, Roberts J, Tombs M, Grant S, Rubin E. Leucovorin, 5-fluorouracil, and gemcitabine: A phase I study. Investigational New Drugs 1999, 17: 57-61. PMID: 10555123, DOI: 10.1023/a:1006239200772.Peer-Reviewed Original ResearchConceptsCombination of leucovorinECOG performance status 0Refractory solid tumor malignanciesMedian performance statusPerformance status 0Phase I trialSolid tumor malignanciesTreatment of lungPrior chemotherapyPrior therapyStatus 0Performance statusStarting doseHepatic reserveI trialPartial responseMedian ageGemcitabine administrationDisease progressionDrug sequenceBreast cancerChemotherapy agentsMedian numberLeucovorinDay 28