2017
Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial
Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O’Connor T, Velasco MR, Weckstein D, O’Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA 2017, 317: 48-58. PMID: 28030702, PMCID: PMC5321662, DOI: 10.1001/jama.2016.19425.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBone and BonesBone Density Conservation AgentsBone NeoplasmsBreast NeoplasmsDiphosphonatesDrug Administration ScheduleFemaleHumansImidazolesMaleMiddle AgedMultiple MyelomaPain MeasurementProstatic NeoplasmsSample SizeSpinal Cord CompressionSpinal FracturesZoledronic AcidConceptsSkeletal morbidity rateProportion of patientsDosing groupZoledronic acidBone metastasesMultiple myelomaProstate cancerBreast cancerSkeletal eventsKidney dysfunctionBone turnoverMorbidity rateClinical trialsEastern Cooperative Oncology Group performance statusOpen-label clinical trialEnd pointIncidence of osteonecrosisYear of randomizationPerformance status scorePrimary end pointSecondary end pointsBrief Pain InventoryMetastatic breast cancerMetastatic prostate cancerAcceptable treatment option
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
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
2011
Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory B-Cell Neoplasms
Holkova B, Perkins EB, Ramakrishnan V, Tombes MB, Shrader E, Talreja N, Wellons MD, Hogan KT, Roodman GD, Coppola D, Kang L, Dawson J, Stuart RK, Peer C, Figg WD, Kolla S, Doyle A, Wright J, Sullivan DM, Roberts JD, Grant S. Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory B-Cell Neoplasms. Clinical Cancer Research 2011, 17: 3388-3397. PMID: 21447728, PMCID: PMC3096752, DOI: 10.1158/1078-0432.ccr-10-2876.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityCombination of bortezomibFebrile neutropeniaPharmacodynamic studiesDay 1Refractory B-cell neoplasmsElevated aspartate aminotransferase levelsCommon hematologic toxicityCommon nonhematologic toxicitiesPhase II studyRefractory multiple myelomaPhase I studiesAspartate aminotransferase levelsB-cell malignanciesB-cell neoplasmsHematologic toxicityIntravenous pushNonhematologic toxicityStable diseaseAminotransferase levelsI trialII studyPartial responseComplete responseDose escalation
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
2003
Phase I studies of weekly administration of cytotoxic agents: Implications of a mathematical model
McClish DK, Roberts JD. Phase I studies of weekly administration of cytotoxic agents: Implications of a mathematical model. Investigational New Drugs 2003, 21: 299-308. PMID: 14578680, DOI: 10.1023/a:1025464510639.Peer-Reviewed Original Research
2000
Phase I study of AG2034, a targeted GARFT inhibitor, administered once every 3 weeks
Roberts J, Shibata S, Spicer D, McLeod H, Tombes M, Kyle B, Carroll M, Sheedy B, Collier M, Pithavala Y, Paradiso L, Clendeninn N. Phase I study of AG2034, a targeted GARFT inhibitor, administered once every 3 weeks. Cancer Chemotherapy And Pharmacology 2000, 45: 423-427. PMID: 10803927, DOI: 10.1007/s002800051012.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase II doseCumulative toxicityAdvanced malignanciesIntravenous bolusAUC0-24Pharmacodynamic factorsFolate supplementationPlasma concentrationsIntermediate dosePharmacokinetic analysisDose levelsELISA assaysDosePhase IAG2034Progressive increaseGARFT inhibitorToxicityWeeksInhibitorsMucositisThrombocytopeniaDiarrheaHyperbilirubinemiaWeekly lometrexol with daily oral folic acid is appropriate for phase II evaluation
Roberts J, Poplin E, Tombes M, Kyle B, Spicer D, Grant S, Synold T, Moran R. Weekly lometrexol with daily oral folic acid is appropriate for phase II evaluation. Cancer Chemotherapy And Pharmacology 2000, 45: 103-110. PMID: 10663624, DOI: 10.1007/s002800050017.Peer-Reviewed Original ResearchConceptsDaily oral folic acidOral folic acidDose omissionsFolic acidDose combinationWeekly scheduleEarlier Phase I trialPredose plasma samplesPhase II dosePhase II trialDose-limiting toxicityPhase I trialPhase II evaluationRed blood cell contentSevere toxic eventsRenal cell carcinomaDays of treatmentAppropriate dose combinationBlood cell contentInfusion weeklyStable diseaseII trialDose intensityPartial responseWeekly administration
1998
Phase Ib trial of bryostatin 1 in patients with refractory malignancies.
Grant S, Roberts J, Poplin E, Tombes MB, Kyle B, Welch D, Carr M, Bear HD. Phase Ib trial of bryostatin 1 in patients with refractory malignancies. Clinical Cancer Research 1998, 4: 611-8. PMID: 9533528.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsBryostatinsCohort StudiesCytotoxicity, ImmunologicDrug Administration ScheduleFemaleHumansImmunophenotypingInfusions, IntravenousInterleukin-2LactonesLymphocyte ActivationLymphocytesLymphomaMacrolidesMaleMetabolic Clearance RateMiddle AgedNeoplasmsPatient SelectionPlatelet AggregationProtein Kinase CConceptsPhase Ib trialIb trialCohort 3Lymphokine-activated killer cell activityBryostatin 1Bryostatin-1 administrationObjective clinical responsesKiller cell activityLiver function testsSubset of patientsBryostatin 1 treatmentSignificant posttreatment increasePKC activitySplit courseClinical responseFirst doseLiver metastasesNonhematological malignanciesRefractory malignanciesFunction testsPatient cohortCohort 1Interleukin-2Immunophenotypic profileTransient elevation
1990
Phase I trial of intraperitoneal recombinant interleukin-2/lymphokine-activated killer cells in patients with ovarian cancer.
Stewart JA, Belinson JL, Moore AL, Dorighi JA, Grant BW, Haugh LD, Roberts JD, Albertini RJ, Branda RF. Phase I trial of intraperitoneal recombinant interleukin-2/lymphokine-activated killer cells in patients with ovarian cancer. Cancer Research 1990, 50: 6302-10. PMID: 2205379.Peer-Reviewed Original ResearchConceptsLymphokine-activated killer cellsRecombinant interleukin-2LAK activityIL-2Killer cellsDose levelsMononuclear cellsUnits/m2 body surface areaIntraperitoneal recombinant interleukin-2M2 body surface areaLAK/ILOvarian cancer refractorySerum IL-2Less IL-2Dose-limiting toxicityPhase I trialIL-2 levelsAdditional IL-2IL-2-dependent cell lineBody surface areaSignificant weight gainMononuclear cell collectionPeripheral blood cellsHighest dose levelCancer refractory
1987
Phase I trial of tiazofurin administered by i.v. bolus daily for 5 days, with pharmacokinetic evaluation.
Roberts JD, Stewart JA, McCormack JJ, Krakoff IR, Culham CA, Hartshorn JN, Newman RA, Haugh LD, Young JA. Phase I trial of tiazofurin administered by i.v. bolus daily for 5 days, with pharmacokinetic evaluation. Journal Of The National Cancer Institute 1987, 71: 141-9. PMID: 3802111.Peer-Reviewed Original ResearchConceptsTreatment interruptionTransient toxic effectsM2/dayTreatment coursePhase I clinical trialToxic effectsAntitumor activityPhase II trialPhase I trialBolus IV infusionFrequent treatment interruptionsSerum biochemical abnormalitiesSystemic toxic effectsCoadministration of allopurinolMurine tumor modelsUric acid productionLow dose levelsSignificant antitumor activityBolus dailyInjury manifestTransient pericarditisII trialSerum hemoglobinI trialIV infusion