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
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
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
2001
Adoptive immunotherapy of cancer with pharmacologically activated lymph node lymphocytes: a pilot clinical trial
Bear H, Roberts J, Cornell D, Tombes M, Kyle B. Adoptive immunotherapy of cancer with pharmacologically activated lymph node lymphocytes: a pilot clinical trial. Cancer Immunology, Immunotherapy 2001, 50: 269-274. PMID: 11499810, PMCID: PMC11036846, DOI: 10.1007/s002620100199.Peer-Reviewed Original ResearchConceptsIL-2 infusionAdoptive immunotherapyClinical trialsInterleukin-2Low-dose interleukin-2Tumor-sensitized T cellsPhase I clinical trialLymph node cellsPilot clinical trialLymph node lymphocytesTarget cell numberCell numberNode lymphocytesNode cellsTumor regressionT cellsT lymphocytesUnexpected toxicitiesMurine modelAdditional trialsInfusionPhase ITrialsTechnical modificationsPatient cells
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 pathwayPhase 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 inhibitorToxicityWeeksInhibitorsMucositisThrombocytopeniaDiarrheaHyperbilirubinemia
1988
Phase I clinical and pharmacokinetic study of trimetrexate using a daily x5 schedule.
Stewart JA, McCormack JJ, Tong W, Low JB, Roberts JD, Blow A, Whitfield LR, Haugh LD, Grove WR, Lopez AJ. Phase I clinical and pharmacokinetic study of trimetrexate using a daily x5 schedule. Cancer Research 1988, 48: 5029-35. PMID: 2970294.Peer-Reviewed Original ResearchConceptsWhite blood cellsM2/dGood performance status patientsMedian white blood cellPhase IDaily x5 schedulePhase II trialPharmacokinetic studyColon 26 tumorMurine i.Nonhematological toxicitiesPlatelet nadirsPrior therapyII trialStarting doseStatus patientsDose escalationTerminal eliminationDose administeredPlatelet toxicityDaily dosesSchedule dependencyPharmacokinetic analysisB16 melanomaDose levels