2018
A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma
Yazbeck V, Shafer D, Perkins EB, Coppola D, Sokol L, Richards KL, Shea T, Ruan J, Parekh S, Strair R, Flowers C, Morgan D, Kmieciak M, Bose P, Kimball A, Badros AZ, Baz R, Lin HY, Zhao X, Reich RR, Tombes MB, Shrader E, Sankala H, Roberts JD, Sullivan D, Grant S, Holkova B. A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2018, 18: 569-575.e1. PMID: 30122201, DOI: 10.1016/j.clml.2018.05.023.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisProspective StudiesSalvage TherapySurvival RateVorinostatConceptsLarge B-cell lymphomaPhase II trialStable diseaseProgressive diseaseB-cell lymphomaPartial responseII trialCohort BCohort ADay 1Median progression-free survivalNonrandomized phase II trialDiffuse large B-cell lymphomaProgression-free survivalHistone deacetylase inhibitor vorinostatOverall response rateCombination of bortezomibMantle cell lymphomaNF-κB activationProteasome inhibitor bortezomibCell lymphoma cellsPresent multicenterRefractory MCLClinical responseCohort C
2016
A Phase II Trial of AZD6244 (Selumetinib, ARRY-142886), an Oral MEK1/2 Inhibitor, in Relapsed/Refractory Multiple Myeloma
Holkova B, Zingone A, Kmieciak M, Bose P, Badros AZ, Voorhees PM, Baz R, Korde N, Lin HY, Chen JQ, Herrmann M, Xi L, Raffeld M, Zhao X, Wan W, Tombes MB, Shrader E, Weir-Wiggins C, Sankala H, Hogan KT, Doyle A, Annunziata CM, Wellons M, Roberts JD, Sullivan D, Landgren O, Grant S. A Phase II Trial of AZD6244 (Selumetinib, ARRY-142886), an Oral MEK1/2 Inhibitor, in Relapsed/Refractory Multiple Myeloma. Clinical Cancer Research 2016, 22: 1067-1075. PMID: 26446942, PMCID: PMC4775365, DOI: 10.1158/1078-0432.ccr-15-1076.Peer-Reviewed Original ResearchConceptsRefractory multiple myelomaPartial responseMultiple myelomaRelapsed/Refractory Multiple MyelomaMedian progression-free survival timeResponse rateProgression-free survival timeTwo-stage Simon designCommon grade 3Good partial responsePhase II studyPhase II trialMEK1/2 inhibitorSignificant preclinical activityMultiple myeloma cellsPrior therapyStable diseaseII trialClinical responseII studyProgressive diseaseMedian ageMean durationPreclinical activityDisease progression
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
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
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
2001
RTOG 9706: initial report of a phase I/II trial of bladder-conservation employing TURB, accelerated irradiation sensitized with Cisplatin followed by adjuvant MCV chemotherapy
Hagan M, Winter K, Kaufman D, Shipley W, Heney N, Toonkel L, Jones C, Roberts J. RTOG 9706: initial report of a phase I/II trial of bladder-conservation employing TURB, accelerated irradiation sensitized with Cisplatin followed by adjuvant MCV chemotherapy. International Journal Of Radiation Oncology • Biology • Physics 2001, 51: 14. DOI: 10.1016/s0360-3016(01)01849-1.Peer-Reviewed Original Research
2000
Weekly 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
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
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