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 investigationMedical marijuana certification for patients with sickle cell disease: a report of a single center experience
Curtis SA, Lew D, Spodick J, Hendrickson JE, Minniti CP, Roberts JD. Medical marijuana certification for patients with sickle cell disease: a report of a single center experience. Blood Advances 2020, 4: 3814-3821. PMID: 32790846, PMCID: PMC7448584, DOI: 10.1182/bloodadvances.2020002325.Peer-Reviewed Original ResearchConceptsOpioid useMedical marijuanaSickle cell disease (SCD) reportBaseline opioid useSingle-center experienceHealth care utilizationSickle cell diseaseOpioid utilizationClinical characteristicsMost patientsCenter experienceCare utilizationSCD patientsInpatient hospitalizationRandom patientsAdmission ratesCell diseasePatientsRetrospective dataDisease reportsStudy periodHealth careCannabis productsCannabisEdible cannabis products
2019
Inpatient pain management in sickle cell disease
Zassman SM, Zamora FJ, Roberts JD. Inpatient pain management in sickle cell disease. American Journal Of Health-System Pharmacy 2019, 76: 1965-1971. PMID: 31605120, DOI: 10.1093/ajhp/zxz228.Peer-Reviewed Original ResearchVaso-occlusive crisisSickle cell diseasePatient-controlled analgesiaOral opioidsParenteral opioidsAcute painPain controlCell diseaseAverage daily pain scoreDaily pain scoresInpatient pain managementAdequate pain controlEmergency department visitsInherited blood disorderOral regimenOpioid usagePain scoresSevere painDepartment visitsHospital admissionPain managementIncremental dosesOpioidsCommon reasonPatientsRed blood cell alloimmunization is associated with lower expression of FcγR1 on monocyte subsets in patients with sickle cell disease
Balbuena‐Merle R, Curtis SA, Devine L, Gibb DR, Karafin MS, Luckey CJ, Tormey CA, Siddon AJ, Roberts JD, Hendrickson JE. Red blood cell alloimmunization is associated with lower expression of FcγR1 on monocyte subsets in patients with sickle cell disease. Transfusion 2019, 59: 3219-3227. PMID: 31355970, PMCID: PMC7075520, DOI: 10.1111/trf.15463.Peer-Reviewed Original ResearchConceptsSickle cell diseaseMonocyte subsetsTotal monocytesCell diseaseComplications of SCDRed blood cell alloimmunizationRed blood cell alloantibodiesElectronic medical recordsTransfusion exposureSerum cytokinesIntermediate monocytesRBC alloantibodiesInflammatory milieuCD64 expressionClassical monocytesPeripheral bloodInflammatory functionsMedical recordsAntibody formationClinical significancePatientsMonocytesFlow cytometryLow expressionResponders
2018
Medical Marijuana Certification for Patients with Sickle Cell Disease: A Survey Study of Patient's Use and Preferences
Curtis S, Spodick J, Lew D, Roberts J. Medical Marijuana Certification for Patients with Sickle Cell Disease: A Survey Study of Patient's Use and Preferences. Blood 2018, 132: 1094. DOI: 10.1182/blood-2018-99-118345.Peer-Reviewed Original ResearchMedical marijuanaOpioid useExact testSickle cell disease clinicMarijuana usePain medication useLess pain medicationEfficacy of marijuanaSickle cell diseaseFisher's exact testImproved safety profileMedical marijuana certificationSCD clinicPain medicationAdult patientsClinic visitsDisease clinicMedication useSymptom managementLess painSafety profileLung toxicityCell diseaseOpiate usePatientsMarijuana Use in Adults Living with Sickle Cell Disease
Roberts JD, Spodick J, Cole J, Bozzo J, Curtis S, Forray A. Marijuana Use in Adults Living with Sickle Cell Disease. Cannabis And Cannabinoid Research 2018, 3: 162-165. PMID: 30014039, PMCID: PMC6044416, DOI: 10.1089/can.2018.0001.Peer-Reviewed Original ResearchSickle cell diseaseCell diseaseMedical marijuanaMarijuana useUrine drug testsPossible therapeutic effectsUrine drug testingAcademic medical centerTertiary careTherapeutic effectMedical CenterPatient's requestPatientsDiseaseQualifying conditionsDrug testsDrug testingCannabinoidsActive constituentsMarijuanaMedicinal indicationsPhencyclidineAdultsInstitutional recordsRecreational use
2017
Comorbidity, Pain, Utilization, and Psychosocial Outcomes in Older versus Younger Sickle Cell Adults: The PiSCES Project
McClish DK, Smith WR, Levenson JL, Aisiku IP, Roberts JD, Roseff SD, Bovbjerg VE. Comorbidity, Pain, Utilization, and Psychosocial Outcomes in Older versus Younger Sickle Cell Adults: The PiSCES Project. BioMed Research International 2017, 2017: 4070547. PMID: 28459058, PMCID: PMC5387810, DOI: 10.1155/2017/4070547.Peer-Reviewed Original ResearchConceptsSickle Cell Epidemiology StudyHealth care utilizationPain daysPiSCES projectPain frequencyAmbulatory visitsPain intensityCare utilizationPainComorbiditiesEpidemiology studiesPsychosocial measuresAge groupsAdult groupPsychosocial outcomesPsychosocial variablesOlder adultsSomatic complaintsHealth careBehavioral coping strategiesTransition groupFurther studiesPatientsAdultsSCD
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
Daily 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
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 objective
2010
A phase I pharmacokinetic study of pulse-dose vorinostat with flavopiridol in solid tumors
Dickson MA, Rathkopf DE, Carvajal RD, Grant S, Roberts JD, Reid JM, Ames MM, McGovern RM, Lefkowitz RA, Gonen M, Cane LM, Dials HJ, Schwartz GK. A phase I pharmacokinetic study of pulse-dose vorinostat with flavopiridol in solid tumors. Investigational New Drugs 2010, 29: 1004-1012. PMID: 20461440, PMCID: PMC3545439, DOI: 10.1007/s10637-010-9447-x.Peer-Reviewed Original ResearchConceptsSerum levelsPhase I pharmacokinetic studyIntermittent high doseResults 34 patientsD1-3I pharmacokinetic studyCyclin-dependent kinase inhibitor flavopiridolKinase inhibitor flavopiridolStable diseaseOral doseOral dosingHigh doseCombination treatmentPatientsSolid tumorsCmaxOne weekDosePharmacokinetic studyVorinostatMTDFlavopiridolNeutropeniaChemotherapyLevels
2009
Phase I study of bryostatin 1, a protein kinase C modulator, preceding cisplatin in patients with refractory non-hematologic tumors
Pavlick AC, Wu J, Roberts J, Rosenthal MA, Hamilton A, Wadler S, Farrell K, Carr M, Fry D, Murgo AJ, Oratz R, Hochster H, Liebes L, Muggia F. Phase I study of bryostatin 1, a protein kinase C modulator, preceding cisplatin in patients with refractory non-hematologic tumors. Cancer Chemotherapy And Pharmacology 2009, 64: 803. PMID: 19221754, PMCID: PMC3901370, DOI: 10.1007/s00280-009-0931-y.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsPhase INon-hematologic tumorsPhase II dosesPhase II doseDose-limiting toxicityResultsFifty-three patientsBlood mononuclear cellsNon-hematologic malignanciesBryostatin 1Cytotoxicity of cisplatinCisplatin 50PurposePreclinical dataObjective responseContinuous infusionMononuclear cellsTolerable dosesProtein kinase C modulatorsCisplatin effectComputerized tomographyPatientsConsistent inhibitionCisplatin cytotoxicityCisplatinMinimal toxicity
2008
Comparisons of High Versus Low Emergency Department Utilizers in Sickle Cell Disease
Aisiku IP, Smith WR, McClish DK, Levenson JL, Penberthy LT, Roseff SD, Bovbjerg VE, Roberts JD. Comparisons of High Versus Low Emergency Department Utilizers in Sickle Cell Disease. Annals Of Emergency Medicine 2008, 53: 587-593. PMID: 18926599, DOI: 10.1016/j.annemergmed.2008.07.050.Peer-Reviewed Original ResearchConceptsSickle cell disease patientsHigh ED utilizersSickle cell diseaseDisease patientsEmergency departmentCell diseaseQuality of lifeFrequency of painSickle cell painDescriptors of painBaseline dataLower hematocrit levelsHealth dataPain daysMore transfusionsPain characteristicsPain crisisED utilizationLaboratory variablesHigh utilizersMore painPainHematocrit levelsPatientsSummary scalesDaily assessment of pain in adults with sickle cell disease.
Smith WR, Penberthy LT, Bovbjerg VE, McClish DK, Roberts JD, Dahman B, Aisiku IP, Levenson JL, Roseff SD. Daily assessment of pain in adults with sickle cell disease. Annals Of Internal Medicine 2008, 148: 94-101. PMID: 18195334, DOI: 10.7326/0003-4819-148-2-200801150-00004.Peer-Reviewed Original ResearchConceptsSickle cell diseasePain daysSelf-reported painCell diseasePain intensityPatients age 16 yearsMean pain intensityProspective cohort studyUtilization daysHealth care utilizationDiary daysAge 16 yearsHealth care providersCohort studyMaximum painIndependent predictorsCare utilizationPainful episodesOpiate useAmbulatory careCare providersPainDaily assessmentPatientsDisease
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
2006
Phase I Study of Bryostatin 1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent (Non-Hodgkin's) Lymphoma
Roberts JD, Smith MR, Feldman EJ, Cragg L, Millenson MM, Roboz GJ, Honeycutt C, Thune R, Padavic-Shaller K, Carter WH, Ramakrishnan V, Murgo AJ, Grant S. Phase I Study of Bryostatin 1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent (Non-Hodgkin's) Lymphoma. Clinical Cancer Research 2006, 12: 5809-5816. PMID: 17020988, DOI: 10.1158/1078-0432.ccr-05-2730.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBryostatinsDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinMacrolidesMaleMaximum Tolerated DoseMiddle AgedPrognosisSurvival RateVidarabineConceptsChronic lymphocytic leukemiaIndolent lymphomaLymphocytic leukemiaBryostatin 1Dose-limiting toxic eventsTreatment of CLLMonoclonal antibodiesPhase II dosePhase II dosesPhase II studyCD20 monoclonal antibodyII studyPersistent diseaseSuccessive patientsSingle doseContinuous infusionI studiesHematologic malignanciesPreclinical studiesTherapeutic effectFludarabinePatientsPrior treatmentLymphomaPhase I
2005
Use of an implantable drug delivery system for refractory chronic sickle cell pain
Smith TJ, Coyne PJ, Smith WR, Roberts JD, Smith V. Use of an implantable drug delivery system for refractory chronic sickle cell pain. American Journal Of Hematology 2005, 78: 153-154. PMID: 15682408, DOI: 10.1002/ajh.20252.Peer-Reviewed Original ResearchConceptsImplantable intrathecal drug delivery systemsSickle cell patientsCell patientsChronic sickle cell painIntrathecal drug delivery systemsRefractory bone painRefractory cancer painSustained-release opioidsSickle cell painRandomized clinical trialsComprehensive medical managementBone painCancer painRefractory painProspective trialSustained reliefMedical managementCancer patientsDrug delivery systemsClinical trialsPainClinical successPatientsDelivery systemImplantable drug delivery systems
2002
Phase I Study of Bryostatin-1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma
Roberts JD, Smith MR, Feldman EJ, Cragg L, Grant S. Phase I Study of Bryostatin-1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2002, 3: 184-188. PMID: 12521398, DOI: 10.3816/clm.2002.n.025.Peer-Reviewed Original ResearchHigher 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
2000
Pharmacokinetic and pharmacodynamic evaluation of the glycinamide ribonucleotide formyltransferase inhibitor AG2034.
McLeod HL, Cassidy J, Powrie RH, Priest DG, Zorbas MA, Synold TW, Shibata S, Spicer D, Bissett D, Pithavala YK, Collier MA, Paradiso LJ, Roberts JD. Pharmacokinetic and pharmacodynamic evaluation of the glycinamide ribonucleotide formyltransferase inhibitor AG2034. Clinical Cancer Research 2000, 6: 2677-84. PMID: 10914709.Peer-Reviewed Original ResearchConceptsGlycinamide ribonucleotide formyltransferaseCourse 1Systemic clearanceGrade III/IV toxicityGrade II toxicityMin/m2Rapid systemic clearanceVolume of distributionEvaluable patientsSystemic exposurePharmacodynamic evaluationClinical centersBolus injectionPharmacokinetic approachBlood samplesPatient toxicityPatientsElimination patternReproducible ELISAAG2034Course 3Phase IAnticancer agentsPurine synthesis pathwayDe novo purine synthesis pathway