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
2005
Phase I Study of Flavopiridol in Combination with Imatinib Mesylate (STI571, Gleevec) in Bcr/Abl+ Hematological Malignancies.
Grant S, Karp J, Koc O, Cooper B, Luger S, Figg W, Egorin M, Druker B, Jacobberger J, Ramakrishnan V, Perkins E, Colevas A, Roberts J. Phase I Study of Flavopiridol in Combination with Imatinib Mesylate (STI571, Gleevec) in Bcr/Abl+ Hematological Malignancies. Blood 2005, 106: 1102. DOI: 10.1182/blood.v106.11.1102.1102.Peer-Reviewed Original ResearchComplete hematological remissionAcute lymphocytic leukemiaBCR/Dose levelsHematological remissionStratum 2Dose level 3Dose level 4Weekly x 3Phase II doseStratum 1Phase II trialDaily oral dosingLeukemia cellsPhase I trialRecent preclinical studiesLeukemic cell deathBCR/ABL kinasePost-treatment effectsEligible patientsBlast percentageCyclin-dependent kinase inhibitorFrequent toxicitiesII trialObjective response
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
1991
A phase i clinical trial of didemnin B
Stewart J, Low J, Roberts J, Blow A. A phase i clinical trial of didemnin B. Cancer 1991, 68: 2550-2554. PMID: 1933801, DOI: 10.1002/1097-0142(19911215)68:12<2550::aid-cncr2820681203>3.0.co;2-q.Peer-Reviewed Original ResearchConceptsM2/dDrug-induced liver dysfunctionPhase I clinical trialPhase II doseHepatic enzyme levelsDose-limiting toxicityComplete tumor responseCastor oil vehicleMurine B16 melanomaDidemnin BBolus scheduleClinical bleedingLiver dysfunctionAdvanced cancerAnaphylactic symptomsTumor responseClinical trialsDrug infusionL1210 growthOil vehicleM5076 sarcomaB16 melanomaDose levelsSporadic elevationsToxicologic tests